A new white paper from the Real-World Evidence Collaborative considers how Real-World Evidence can support product effectiveness labeling changes through a totality of evidence approach.
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Starting with the 2019 plan year, Medicare Advantage (MA) plans are able to offer expanded supplemental benefits that support their members’ broader health needs. New regulations and guidance from the Centers for Medicare & Medicaid Services (CMS) allow MA plans to offer benefits that are...
Randomized, blinded, and controlled trials are the gold standard for establishing product effectiveness. However, stakeholders throughout the health care environment (i.e., sponsors, regulators, payers, providers, and patients) are eager to leverage real-world data (RWD) and real-world evidence...
A new paper by the Duke-Margolis Center for Health Policy provides a systematic framework to characterize the reliability of real-world data (RWD) to support fitness for use in drug development and regulation. RWD is information about patient health status and health care delivery routinely...
On June 24, 2019, President Trump released an Executive Order (EO) seeking to empower patient decision-making by promoting transparency on price and quality. The EO dovetails congressional efforts to pass an omnibus legislative bill, the Lower Health Care Costs Act of 2019, which includes...
Changes by the Food and Drug Administration (FDA) to drug safety labeling are an important way to provide patients and providers with the most up-to-date information about a product’s risk. However, too little is known about the impact of these changes on health systems behavior and patient...
Artificial intelligence (AI) systems and applications is now poised to disrupt healthcare, with the potential to improve patient outcomes, reduce costs, and enhance work-life balance for healthcare providers through integration with clinical decision support (CDS) software.
AI-enabled...
The Duke-Margolis Center for Health Policy and the Global Health Innovation Center at Duke University conducted a study to review progress of and identify steps to advance integrated care models in the National Health Service (NHS) in England. Implementing these care models is a priority for NHS...
Employer-sponsored health insurance plans face rising costs that impact firms’ bottom lines and employee wages. In response, many employers have adopted cost-sharing strategies, such as high deductible health plans, but there may be limits to how well these designs can contain costs and improve...
