Life Science Topics - Regulation

The global compliance landscape is challenging and constantly evolving. Business complexity is increasing, and enforcement risks are intensifying. As a result, we must continuously assess whether we have the tools necessary to proactively identify and manage risks, and ensure these tools engage the entire organization in the compliance process. Understanding our compliance data is becoming [...]

Life science organizations are dedicated to developing and manufacturing transformative products that enhance lives. To accomplish this mission, they routinely contract with healthcare professionals (HCPs) to research, develop, market and train on these products. HCPs contribute invaluable insights, expertise and medical credibility by providing both a theoretical and practical approach to the products and treatments. [...]

Life sciences professionals engaged in transparency reporting understand the myriad of challenges in compiling necessary data for reporting. Navigating challenges such as incomplete records, discrepancies among data sources, duplicate, or late data submissions can significantly compromise the accuracy of reporting. Compliance and transparency teams often endure heightened stress and sleepless nights over these common issues, [...]

MediSpend’s legal experts recently presented a webinar shedding light on the recent transparency updates within the life science industry. The presentation covered key topics, such as updates to CMS’ Open Payments reporting, various state considerations and the newly issued OIG General Compliance Program Guidance. Notably, the webinar highlighted recent developments in compliance regulations in both Italy and [...]

On November 6, 2023, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), in connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance community and other healthcare stakeholders. During [...]

MediSpend’s Advisory Services team recently presented a webinar on emerging transparency updates and requirements for pharmaceutical and medical device manufacturers. Notable updates included changes to the Centers for Medicare & Medicaid Services (CMS) Open Payments reporting, Connecticut’s new sales representative disclosure requirements and an update on the Italian Sunshine Act. CMS Open Payments Updates Numerous [...]