Health Policy Update: February 2022
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The Duke-Margolis community congratulates Duke faculty member and alumnus Rob Califf, who was confirmed as the commissioner of the U.S. Food and Drug Administration by a vote of the full U.S. Senate and sworn into his post by HHS Secretary Becerra on February 22 nd. Center Director Mark McClellan, along with five other former FDA Commissioners, actively supported his nomination in a letter to the US Senate HELP Committee. Mark, together with Scott Gottlieb, Margaret Hamburg and Andy Slavitt, penned an op-ed in The Hill detailing the myriad of important issues with which the FDA is currently dealing including the COVID-19 pandemic. Read the full op-ed here.
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Former Duke-Margolis Senior Policy Fellow Susan Dentzer has been named the new President and CEO of America’s Physician Groups (APG). When ask about this new opportunity, Susan noted that she is “honored to take the helm at APG at this critically important time in the transition to value-based care.” Susan has been involved with the Center since its inception and will continue as a member of the e Duke-Margolis Advisory Board. We wish you the best of luck, Susan!
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COVID-19 RESPONSE:
HEALTH POLICY IN ACTION
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Director Mark McClellan joined a Duke University Media Briefing to discuss the future of COVID-19, future variants, and what may have to happen to stay safe in the event of another COVID surge similar to Omicron. Watch the full briefing here.
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In an interview with the Raleigh News & Observer, Director Mark McClellan discussed the Omicron surge while sharing optimism that better days are possible. “If we’re able to continue the decline in the surge at the rate that’s been happening the past week, I do see some real opportunities for relaxing mask mandates, for relaxing our activities, just within the next month, not too far off at all,” he said. He also discussed that less than a third of the five to 11-year old children has been vaccinated, and underscored that the data shows that vaccines can prevent serious illness and long-term complications from COVID in kids. Read the full article here.
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Duke-Margolis, through the efforts of its Biomedical Innovation team, responded to the Centers for Medicare & Medicaid Services’ (CMS) proposed decision memo regarding the use of monoclonal antibodies (mAbs) against amyloid for the treatment of Alzheimer’s disease (AD). The Center provided recommendations to CMS to refine their proposed coverage decision in light of the evolving body of evidence for mAb treatments and to address the priorities of patient access, equity, and further needed evidence development. Read the Center’s response here.
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Duke-Margolis sent substantive comments to the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee on its discussion draft of the bipartisan legislation, “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act”). While the Center commended the committee’s efforts to move forward a critical set of pandemic preparedness and response measures, it also proposed a number of revisions, refinements, or additions to other proposals found throughout PREVENT. These recommendations reflect two years of the Center’s COVID-19 work focused on response policies, vaccine and therapeutic development, testing strategies, and health sector resilience, including more than 50 white papers, policy briefs, and commentaries; multiple Congressional testimonies; and over 20+ public events. Click here to read the Center’s full response.
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Center Core Faculty Member Charlene Wong co-authored an article in JAMA Pediatrics entitled “Screening for Health-Related Social Needs in Pediatric Value-Based Care,” that describes how health-related social needs are critical factors in children’s health that can be assessed through informal questioning or use of formal screening instruments. Read the article here.
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AI/Machine Learning: Regulation, Development, and Real-World Performance Evaluation
March 22, 2022
12:30 – 4:00 PM ET
Duke-Margolis Center of Health Policy, with participation from the U.S. Food and Drug Administration (FDA) speakers and panelists, will hold a public webinar to spotlight updates and progress made since the release of FDA’s Artificial Intelligence (AI) Action Plan in early 2021.
There will be a fireside chat between Jeff Shuren, FDA’s director of the Center for Devices and Radiological Health (CRDH), and Mark McClellan, director of Duke-Margolis, followed by three panel discussions focused on the following topics:
- overarching frameworks for regulating and evaluating AI
- good machine learning practices (GMLP)
- post-market evaluation of AI/ML SaMD
The webinar will end with a business roundtable discussion on how developers and health care systems are considering these issues.
For more information and to register visit our event website. This webinar is partially supported by The Gordon and Betty Moore Foundation.
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Leveraging Payment Reforms to Transform and Expand Home-Based Care for People with Complex Health Needs
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Duke-Margolis hosted a public webinar to discuss opportunities to expand home-based care for people with complex health and social needs. Home-based care is an untapped resource to provide care to millions of people in the United States who are unable to access or have difficulty obtaining care. This webinar explored immediate policy opportunities to increase home-based care at both the federal and state level, including pathways to use value-based payment models to further expand access to home-based care services.
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The North Carolina Department of Health and Human Service s announced that Duke-Margolis Core Faculty Member Charlene Wong has been named Assistant Secretary for Children and Families for the newly launched, Division of Child and Family Well-Being. Former Margolis Scholar Madhu Vulimiri will serve as the department’s Deputy Director. Read more about the announcement from NCHHS and Duke School of Medicine.
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Center Director Mark McClellan joined a bipartisan group of former FDA Commissioners in a letter supporting the nomination Dr. Califf’s to return as Commissioner of Food and Drugs ahead of his confirmation hearing in the Senate HELP Committee. On January 14 th, Dr. Califf’s nomination passed the Senate HELP Committee and will now be taken up for a vote by the full Senate. A date for the Senate’s vote on confirmation has not been set.
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Sanford School of Public Policy announced that Duke-Margolis Core Faculty Member Nathan Boucher will become the school’s new director of undergraduate studies on July 1, 2022. Read more from the Sanford announcement here.
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Duke Global Health Institute featured Margolis Intern Elaijah Lapay as part of their Student Stories series. In the article, Elaijah details why studying how well health care systems communicate with patients from other cultures is of particular interest to him, an interest shaped by the experience of his immigrant grandmother. Read the full piece here.
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Duke-Margolis Intern Sophie Hurewitz published two blog posts in The Medical Care Blog. The blog topics are closely tied to her own prior research experiences with the Center and the Center’s ongoing work to address health equity and healthcare transformation. The blogs detail the work of the Children's Complex Care Coalition of North Carolina (Path-4CNC), a Duke and UNC collaborative working to improve the systems of care for children with complex health needs in North Carolina. Read more about Sophie’s research here and here.
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Dure Kim, PharmD, is an Assistant Research Director for the Biomedical Innovation portfolio, focusing on the Center’s Cooperative Agreement with the FDA in the advancement of regulatory science and health policy research. Prior to joining Duke-Margolis, he was a Research Scientist at the National Evaluation System for health Technology Coordinating Center, where he helped manage and develop Real-World Evidence studies with medical device stakeholders and researchers. Dure received his Doctor of Pharmacy from Mercer University in 2016 and completed a fellowship in Comparative Effectiveness Research and Patient-Centered Outcomes Research at the University of Maryland, Baltimore in 2018.
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Samantha (Sam) Repka is a Research Associate who supports work across the Center’s health care transformation team. Sam comes to Duke-Margolis from the New York City Department of Health and Mental Hygiene, where she served as a Director of Public Policy. Prior to her time in NYC, she was a Senior Manager at AcademyHealth and a Teach for America Corps Member. She holds a Master of Science in Public Health and a Bachelor of Science in Public Health from the University of North Carolina at Chapel Hill.
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Sarah Dunn Phillips, MA, has taken on the role of Associate Director of Education. Since starting at Duke-Margolis in the Fall of 2019, Sarah has been helping to develop and manage our rapidly growing portfolio of educational programs and working closely with myself, our Faculty Directors, and our staff team to conceptualize and execute educational initiatives to further our mission of training future health policy leaders. As our Center matures and our educational programs grow, so do the roles and responsibilities needed to lead and support these programs and initiatives. In Sarah’s expanded role as Associate Director, she collaborates with the Faculty Directors to provide oversight on all academic and experiential programs, supervises the program coordinators supporting our educational initiatives, furthers our student engagement and mentorship as well as faculty engagement, and serves as a liaison for our education programs both within the Center and across campus.
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Kamaria Kaalund, BA, has been promoted to Policy Analyst, Health Equity. Since starting at Duke-Margolis in June 2020, Kamaria has served as a key research team member on multiple projects including the COVID-19 Health Equity Learning Network, Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP), COVID-19 Testing Strategies Team, and Lancet Commission for Hearing Loss. She was awarded the 2021 Duke-Margolis Leadership Award for her valuable contributions to the Center.
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Opportunities at Duke-Margolis Center for Health Policy
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10 Positions, 10 Chances to Join Our Team!
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Do you want to be part of health policy in action? Do you want to work on the leading health policy issues confronting cities, states, the nation, and the globe? The Duke-Margolis team is a dynamic, high impact national leader in leveraging policy to ensure high quality, affordable care for all. Multiple positions are currently available and new positions have been posted this week! Click here to view all of our career opportunities.
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