Health Policy Update: August 2021
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Duke University School of Medicine’s Magnify Magazine published an in-depth feature on Duke-Margolis Core Faculty Member Charlene Wong. The article tracks her early experiences pursuing health policy through her current role as the Chief Health Policy Officer for COVID-19 for North Carolina’s Department of Health and Human Services (DHHS), where she sits at the helm of the one of the largest public health campaigns that DHHS has ever undertaken. Click here to read more about this “Pediatrician, Policy Expert, & School Principal.”
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COVID-19 RESPONSE:
HEALTH POLICY IN ACTION
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NEW RESOURCE:
Innovative Strategies for Leveraging Schools as Vaccination Sites Issue Brief
Duke-Margolis joined the COVID Collaborative, the Council of the Great City Schools, AASA: The School Superintendents Association, the National Rural Education Association, and the Rural Schools Collaborative to release a new issue brief that features how schools can establish vaccination sites, including examples of innovative district-level approaches for engaging families and vaccine access. Read the brief here.
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Health policy and public health leaders provided recommendations for college and university leadership to use the energy and spirit of the college football season to increase vaccinations in communities. These recommends include setting a goal for teams to be at least 90 percent vaccinated to keep players safe and inspire communities, or even instituting a “vaccination to play” rule. Director Mark McClellan joined the medical directors of the major college sports leagues in endorsing a statement calling for game day safety and #COVIDSafeZones.
With more than 890 colleges and universities, include Duke University, joining the President’s COVID-19 College Vaccine Challenge, the COVID Collaborative and the Autonomy 5 Conferences are working together to encourage vaccinations for teams, students and college sports communities to slow the spread of COVID and protect students from the effects of COVID and Post-Acute Symptomatic COVID (PASC), which is increasingly being recognized among our youth.
The campaign is outlined in opinion pieces in USAToday and The 74, both co-authored by Mark, Andy Slavitt, and John Bridgeland. Read the USAToday op-ed here and click here to read the piece in The 74.
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Director Mark McClellan joined Duke Today for a live press briefing following the FDA’s approval of the Pfizer coronavirus vaccine. Dr. McClellan discussed the timing of the approval process, the benefits of full approval, and the impacts on vaccine mandates across the country. Click here to read more information or watch the video below.
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Listen here as Director Mark McClellan and Andy Slavitt detail the next big moves in the COVID battle, including FDA approvals, clinical trials for kids, boosters, mandates, and what the adverse reporting system really says about vaccine safety.
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GLOBAL
Faculty member Krishna Udayakumar and Director Mark McClellan joined 15 global health leaders and 22 organizations in support of a new Framework for a Global Action Plan for COVID-19 Response. The Framework states “a coordinated, global response, the only possible successful response to the pandemic, must be grounded in equity at all levels–global, regional, national, subnational and community “and urges that “an ‘all hands-on deck’ crisis response must deploy all available resources and capabilities – multilateral and bilateral, public and private sector.” Read the framework here.
#TheArmsRace is a global effort, through British-based Tortoise Media, to get the world vaccinated against COVID as quickly as possible. Mark McClellan joined co-authors Pascal Lamy, president of the Paris Peace Forum, Gary Edson, president of the COVID Collaborative, and Carolyn Reynolds, co-founder of the Pandemic Action Network, in setting out a six-point plan for a COVID pandemic summit, in conjunction with the September 2021 United Nations General Assembly Meeting. Click here to read the op/ed.
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Research Associate Michelle DelFavero and Health Equity Policy Fellow Andrea Thoumi co-authored, in participation with the COVID-19 Health Equity Network, the second case study in an ongoing series which highlights the partnerships in Alaska between the state and tribal leaders to increase vaccinations for Alaska Native populations. The work is supported by the Robert Wood Johnson Foundation and is in collaboration with the National Governors Association and The National Academy for State Health Policy. Click here to read the case study.
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In the summer of 2020, Duke University convened the Latinx Advocacy Team & Interdisciplinary Network for COVID-19 aimed at identifying disparities in care and critical needs for the Latinx community in North Carolina. Duke-Margolis’s own Health Equity Policy Fellow Andrea Thoumi and the other members of the network have worked this past year to improve access to COVID-19 testing and vaccines in the Latin community. Read more about the group and their accomplishments in an article in Duke University’s The Chronicle.
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Core Faculty Member David Ridley and Duke University undergrad Pranav Ganapathy co-authored an analysis for Health Affairs entitled “US Tropical Disease Priority Review Vouchers: Lessons in Promoting Drug Development and Access.” The article investigates the Tropical Disease Priority Review Voucher program, an idea born at Duke which became law in 2016. Read the full analysis here.
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Core Faculty Member Corinna Sorenson and Margolis Scholar Alexander Gunn co-authored “Navigating the high costs of cancer care: opportunities for patient engagement,” where they explore the opportunities to develop and support patient-level strategies that engage patients and consider their preferences, values and individual circumstances. Read the full paper.
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Duke-Margolis researchers Jonathan Gonzalez-Smith, Katie Huber, Robert Saunders teamed up with Core Faculty Members Christine Goertz and Trevor Lentz in co-authoring, “Exemplary Integrated Pain Management Programs: University of Vermont Medical Center Comprehensive Pain Program.” The case study is the second in a series of four case studies highlighting health systems with exemplary pain management programs with successful approaches to delivering integrated pain. Click here to read the full case study.
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David Anderson, research associate at Duke-Margolis, co-authored “Changes in Marketplace Competition and Television Advertising by Insurers” providing evidence on how Health Insurance Marketplace insurers are altering their marketing in response to changes in competitive pressure over time. Click here to read the full study.
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Core Faculty Member Kate Bundorf co-authored a research letter entitled “Analysis of Publicly Funded Reinsurance—Government Spending and Insurer Risk Exposure” Click here to read Kate’s research letter and here for the commentary response co-authored by Center Research Associate Dave Anderson.
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A 2017 diabetes study by Core Faculty Member Frank Wharam was cited in “How the pandemic laid bare America’s diabetes crisis”, the most recent article in the “Out of Control: America’s losing battle against diabetes” series by Reuters. Click here to read the full piece.
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Duke-Margolis welcomes the 2021-2022 Duke-Margolis Scholars in Health Policy and Management! This year we have 39 Scholars all across a multitude of disciplines, interests, and backgrounds. The cohort comprises undergraduates, graduates, medical, and Ph.D. students. We are very excited for the year ahead and can't wait to start working with our cohort. Meet our Scholars in our overview of the Scholars Program at healthpolicy.duke.edu/scholars.
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School-Located Vaccination Strategies to Increase Child and Adolescent Immunization Rates during the COVID-19 Pandemic
Thursday, September 17, 2021
1:00 – 5:00 PM EST
Join Duke-Margolis and the Association of Immunization Managers on September 16, 2021 for a virtual symposium bringing together public health officials, leaders in K-12 education, health care providers, and other stakeholders from across the immunization community to share best practices for improving childhood and adolescent immunization rates in school settings. Speakers will discuss innovative models and lessons learned for school-located COVID-19 vaccination sites, communications strategies for engaging families and building vaccine confidence, and opportunities for strengthening partnerships between public health, education, and health care providers to improve child and adolescent vaccination rates. This event is being sponsored in part by The Rockefeller Foundation.
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Pharmacodynamic Biomarkers for Biosimilar Development and Approval
September 20, 2021 10:00 AM – 2:30 PM EDT
September 21, 2021 10:00 AM – 2:30 PM EDT
Duke-Margolis is collaborating with the U.S. Food and Drug Administration (FDA) to host a two-day virtual public workshop entitled “Pharmacodynamic Biomarkers for Biosimilar Development and Approval” on September 20 – 21, 2021. This virtual public workshop is a forum for regulators, biopharmaceutical developers and academic researchers to discuss the current and future role of pharmacodynamic (PD) biomarkers in improving the efficiency of biosimilar product development and approval.
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Virtual Value-Based Payment Summit Announces Two Complimentary Listening Sessions On CMMI Payment Models
The Virtual Collocated Value-based Care Summit has announced that it will be offering two FREE listening sessions on CMMI payment models which will provide input for CMMI staff on key policy issues.
Monday, September 20, 2021
3:30 – 5:00 PM EDT
Listening Session I: How Can ACO and Specialty Models Co-Exists?
Wednesday, September 22, 2021
3:30 – 5:00 PM EDT
Listening Session II: Supporting Primary Care Practice in Value-Based Care: Primary Care Accountability for Specialty Care Within Federal Initiatives
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On July 21 and 22, 2021 the Duke-Margolis Center for Health Policy hosted a workshop entitled “FDA’s Enterprise Data Modernization,” as part of Duke-Margolis’ cooperative agreement with FDA. The workshop convened stakeholders from across the FDA’s centers, data companies, sponsors, and academia to discuss ways in which the FDA might modernize its data infrastructure in accordance with the goals outlined in the Data Modernization Action Plan (DMAP), which was released in March of 2021. Meeting materials, including a summary document, can be found here.
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On June 28 and 29, 2021, the Duke-Margolis Center for Health Policy convened a private workshop with participants to explore different opioid disposal options available and consider the potential impact and benefits of FDA requiring manufacturers to provide a safe, in-home disposal option when opioids are dispensed. Meeting materials, including a summary document, can be found here.
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Senior Research Director Robert Saunders was quoted in a Modern Healthcare article discussing value-based care and the flexibilities in CMMI’s alterative payment models. Read the full article here.
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A quote by Duke-Margolis’ Digital Health Policy Fellow Christina Silcox, taken during her participation in a CES 2021 panel event in January, was used in a recent mobi health news article entitled “Abbott receives FDA clearance for AI-powered heart imaging software”. Click here to read more.
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Director Mark McClellan was interviewed by USA Today for “'Clock is running out.' As COVID-19 cases climb, Biden faces rising pressure to fill top FDA job.” Read the full article here.
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NEW DUKE-MARGOLIS TEAM MEMBERS
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Matt D'Ambrosio is a new research assistant, also with the Biomedical Innovation portfolio. Matt will support the Center’s Real-World Evidence (RWE) Collaborative engagement efforts as well as the development, execution, completion, and dissemination of various RWE Collaborative workstream deliverables. Previously, he worked in the public health and clinical sectors to provide research, policy, and public engagement support. Matt brings to the Center his academic training in public policy, social sciences, life science, and agriculture, having completed his Bachelor of Science degree in Environment and Sustainability at Cornell University.
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Tiffany Chan, MA, is the new Program Coordinator for our Education Team, where she will work to support and advance the educational experience across the Center and for undergraduate students, in particular. For the majority of her professional career, Tiffany has worked in Student Affairs with undergraduate students. She comes to Duke-Margolis from NC State University where she was the primary lead for all programmatic efforts and moving parts of two Living Learning Communities, and gained experience in student advisement, program management, and evaluation. Tiffany served as an administrator at Brandeis University and Newberry College and is a former intern with Duke’s Office of New Student Programs. She earned her Bachelor’s in Psychology from North Carolina-Wilmington and her Master’s in Applied Educational Psychology from Northeastern University.
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Ethan Chupp joins the Biomedical Innovation portfolio as a new Policy Analyst. In his role, he will focus on the Center’s work to advance regulatory science by providing support for the grants associated with the Center’s cooperative agreement with FDA. Prior to Duke, he worked as a Research Associate for Qtection, performing research and development for diagnostic products. He holds a B.A. in Molecular Biology and Biochemistry from Wesleyan University.
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Duke alumnus Erin Soule, PhD, is a new Assistant Research Director for the Center’s Biomedical Innovation portfolio, where she will work with the medical products development and regulations team, specifically leading the Center’s FDA convener grant. Erin comes to Duke from a two-year AAAS Science and Technology Policy Fellowship at the U.S. Department of Defense. Her placement was with the Laboratories and Personnel Office in Research and Engineering, where she worked across the STEM Education and Outreach, Technology Transfer, and Laboratory Infrastructure portfolios. She also worked as a basic research postdoctoral researcher at the Royal College of Surgeons in Ireland where her projects focused on the intersection of blood coagulation and inflammatory signaling. Erin completed her PhD in Pharmacology and Cancer Biology at Duke University in 2016, where she developed and characterized novel anticoagulant therapeutics. She received her Bachelor’s in molecular biology from Colgate University.
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