In This Issue
Health Policy In Action: A New Tool for Real-World Evidence
Events: Enhancing Adoption of Innovative Clinical Trial Approaches
Team Member Welcome: Chelsea Swanson, MPH
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Save the Date
Duke-Margolis Annual Health Policy Conference
Thursday, April 11, 12:00-5:00 PM ET
The Westin Washington, DC Downtown
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Duke-Margolis Elevated to Institute Status
Duke University advanced its commitment to improving health care quality, equity, and affordability through health policy by announcing the elevation of the Duke-Margolis Center for Health Policy to the Duke-Margolis Institute for Health Policy.
“Since its founding in 2016, and with the continued generous support of Bob and Lisa Margolis, Duke-Margolis has established itself as a national leader in interdisciplinary health policy education, research and engagement,” said Duke University President Vincent E. Price. “As we celebrate the university’s Centennial, recognizing Duke-Margolis with institute status also advances our university-wide efforts to have a transformative impact on the future of health and health care.”
With this new Duke recognition, Duke-Margolis will continue to address timely health policy challenges; amplify Duke’s collective ability to support research and education that impacts health policy locally, nationally, and across the globe; and deepen Duke’s recruitment and retention of dynamic faculty and scholars who will lead, research, and explore the most pressing health care challenges of the future.
“Duke’s recognition will expand our efforts to meet growing student interest, and the growing policy need, for interdisciplinary research and educational programs to advance health care reform and innovation,” said Mark McClellan. “As the Duke-Margolis Institute for Health Policy, we will work to deepen our engagement with Duke faculty, and leverage our successful model for collaboration and partnerships to advance Duke’s bold strategic vision and increase our impact on health policy and health reform.”
Read the Duke Today article here.
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Bass Connections Team Receives Presidential Awards
Program Coordinator Tiffany Chan Justice, and Core Faculty members Beth Gifford, Gavin Yamey, and Tyson Brown, will receive a Duke University Presidential Award this year for their work with the Bass Connections program. The Presidential Awards are given to individuals and teams across Duke that best exemplify Duke’s core values of respect, trust, inclusion, discovery, and excellence. The announcement in Duke Today noted that, since Bass Connections’ start in 2013, “more than 5,500 Duke community members and nearly 600 external partners have been part of Bass Connections projects. The research created through the program has yielded more than $70 million in post-team awards and almost 200 identified scholarly publications.”
Duke-Margolis leads the Bass Connections theme of Health Policy and Innovation, where Tiffany is the Program Coordinator and Beth is the Theme Leader. Gavin is the Global Health Theme Leader and Tyson Brown is the Race and Society Theme Leader. Read more about the awards in the Duke Today article.
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A New Tool for Real-World Evidence
Duke-Margolis’ new International Harmonization of Real-World Evidence Standards Dashboard can help internationally-focused RWE policy stakeholders track relevant and timely regulatory guidance, frameworks, harmonization documents, and other topics. Learn more here.
The Evidence Base also discussed the potential of this new tool in their article, here.
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Evidence Generation Through Real-World Data
Duke-Margolis published a comment letter as feedback to the U.S. Food and Drug Administration (FDA)’s document, “Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence,” to suggest that the FDA might provide more guidance on real-world data usage in gathering confirmatory real-world evidence. Read the comment letter here.
Regulatory Focus summarized the major points of feedback on the FDA document, including those made in Duke-Margolis’ comment letter. Read their article here.
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Supporting Dual-Eligible Beneficiaries
Core Faculty members
Courtney Van Houtven and Brystana Kaufman, and Senior Policy Advisor Aparna Higgins, co-authored a paper in Medical Care on Medicare-Medicaid dual-eligible beneficiaries. The authors studied the effect of Medicare-Medicaid integration models and shared their experiences with linking claims data across the two services. Read more here.
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Preventing Drug Supply Shortages
In a new Health Affairs Forefront article, Duke-Margolis researchers Stephen Colvill, Thomas Roades, Gerrit Hamre, Marianne Hamilton Lopez, and Mark McClellan outline the root causes of drug shortages, along with steps that Medicare can take to help prevent them. The authors propose a Medicare “reliable drug supply payment adjustment,” as Medicare changes implemented with private-payer engagement can help to place appropriate value on the reliable availability of essential generic medicines. Read more here.
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North Carolina State Transformation Collaborative
With support from the North Carolina Department of Health and Human Services, Duke-Margolis hosted a NC State Transformation Collaborative (NC STC) Data Sharing Workgroup meeting. This meeting was the first in a series designed to identify practical alignment strategies that can facilitate data exchange across select measures and lines of business to relieve administrative burden and advance population health. Subscribe to the NC STC newsletter here to learn more about their work.
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Alternative Payment Models in Pediatrics
Policy Analyst Greeshma James, and Core Faculty members Charlene Wong and Rushina Cholera, co-authored a paper in Medical Care Research and Review. The authors reported on perspectives from North Carolina Medicaid managed care organizations and health care actuaries on pediatric alternative payment model (APM) implementation, and made recommendations for future APMs focused on social needs or child health. Read more here.
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Rare Disease Therapeutics
The Pink Sheet reported on the FDA’s recent remarks about rare disease drug development that were made in response to the discussion that arose at a recent Duke-Margolis event: “Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement.” Read the article here.
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Healthy Opportunities Pilots
Our report analyzing the planning, capacity-building, and early implementation of North Carolina’s Healthy Opportunities Pilots program was featured on Milbank Memorial Fund’s list of top five publications in 2023. Read more here.
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Developing Products to Prevent Preterm Birth
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Advancing Children's Health
The Whole Child Alliance released a report on the whole child health approaches in Massachusetts, North Carolina, and Washington. Two examples referenced in the report included the Healthy Opportunities Pilots program and the North Carolina Integrated Care for Kids model, both of which are projects that Duke-Margolis helps to support through research. Read the report here.
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Enhancing Adoption of Innovative Clinical Trial Approaches
March 19, 2024 | 10:00 AM – 5:00 PM ET
March 20, 2024 | 12:30 – 5:00 PM ET
Clinical trial design and conduct are evolving within the greater transformation of the drug development landscape. While there have been successful efforts to modernize clinical trials, more can be done to advance the adoption of innovative approaches. Duke-Margolis will host a hybrid workshop under a cooperative agreement with the FDA to discuss the considerations and opportunities surrounding clinical trial innovation.
Learn more and register here.
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Bridging a Care Gap: Policy Opportunities for Improving Access to Home-Based Primary Care for Rural Populations
This webinar discussed unique challenges of implementing home-based primary care in rural areas, care delivery considerations for supporting rural home-based primary care, and policy opportunities to support rural home-based primary care providers and the communities they serve.
Watch the recording here.
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Advancing Hepatitis C Elimination: A Coordinated National Approach
Duke-Margolis developed an evidence-based implementation pathway for a national elimination program that combines strategies for greater access to hepatitis C therapeutics with provider training, disease detection and surveillance, and coordinated care management. This hybrid meeting shared findings from this framework.
Watch the recording here.
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Improving Regulatory Practices to Sustain Antibiotic Innovation
Attendees learned how the regulatory process impacts investment in antibiotic development and commercialization. Key topics included strategies to improve clinical trials, the impact of international regulatory harmonization, and the potential of real-world evidence to augment the regulatory review and clinical success of novel antibiotics.
Watch the recording here.
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Emerging CMMI Models: Aligning to Reduce Burden & Achieve Person-Centered Care in 2024
Attendees heard updates from the Centers for Medicare & Medicaid Services' (CMS) Innovation Center (CMMI) on the CMS vision for accountable care, learned how emerging models are promoting alignment, growth, and equity through common design elements, and discovered how directional alignment among CMMI models could promote person-centered care and reduced burden for accountable providers.
Watch the recording here.
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Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement
Speakers discussed approaches and opportunities for engaging patients, patient groups, rare disease or condition experts, and experts on small population studies during the drug development process for rare diseases. The workshop focused on how to best understand patients’ experiences living with a rare disease and how to incorporate those experiences and priorities throughout the drug development process.
Watch the recording here.
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Bass Connections
We are excited to announce the 2024-2025 Bass Connections projects, 11 of which will be administered by Duke-Margolis and four will be co-led by our Health Policy & Innovation theme. Bass Connections brings together students and faculty from a variety of disciplines to research societal and cultural challenges. To view a list of 2024-2025 projects, please visit the Health Policy & Innovation Theme page.
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Core Faculty member Rushina Cholera co-authored two papers in JAMA Pediatrics:
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Core Faculty member David Ridley co-authored a report in Health Affairs Forefront that explored the FDA’s overseas drug inspection activities, which remain below pre-COVID-19 levels. Read more here.
David also was quoted in an article from The Associated Press that references the report in the context of a recent increase in eyedrop recalls. Read it here.
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Core Faculty member Barak Richman was quoted in an article from The Baltimore Banner that reported on certain Maryland hospitals and their challenge to find and repay the patients they wrongly charged for emergency room visits. Read more here.
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Visiting Fellow and Advisory Board member Farzad Mostashari co-authored an op-ed in Health Affairs Forefront: “Why The Star Ratings Medication Adherence Measures Must Go.” The article argued that the Medicare Star Rating System is no longer a meaningful measurement system for plans and providers. Read more here.
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Margolis Scholar Jack Pitsor (’24) was awarded the David A. Winston Health Policy Fellowship, a 12-month program in Washington, DC that is offered to students with passion for health policy and demonstrated commitment to advancing the field. Scholar Natalie Wong (’24) also was a finalist for this fellowship. Congratulations, Jack and Natalie! Read more in the Sanford School of Public Policy blog post.
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Affiliated Faculty member Charles Scales has been named the new Associate Dean for Clinical Research Initiatives at the Duke University School of Medicine. He will provide strategic vision and oversight of the Clinical Research Units, develop research plans and clinical research recruitment, and oversee the integration of research and health data with technology for clinical research.
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The Pie: An Economics Podcast interviewed Mark McClellan during their episode on the economics of health insurance reform. Listen to it here.
Prescription for Better Access also interviewed Mark in a recent podcast episode, where they discussed the major policy activities to come in 2024 as well as the emerging challenges and opportunities for improving health through artificial intelligence. Listen here.
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The American Heart Association quoted Core Faculty member Adrian Hernandez in their article describing the impact of COVID-19 on the heart, brain, and other organs. Read more here.
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Core Faculty member John Purakal received the Recent Alumni Award, an honor presented by Wayne State University to alumni who have demonstrated outstanding professional achievement or impactful community contributions. Congratulations, John! Learn more about the award here.
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Core Faculty member Brystana Kaufman spoke at Advancing Workforce Analysis and Research for Dementia Network’s event to discuss the Guiding an Improved Dementia Experience payment model and potential impacts on the dementia care workforce. Watch the recording here.
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Research Director Christina Silcox discussed a new machine learning model, life2vec, in an article from Scientific American. The model was developed and studied in Denmark to predict mortality in the research population, and the article explores its potential and limitations.
Christina also participated in two events:
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Chelsea Swanson, MPH, joins Duke-Margolis as an Assistant Research Director and will serve as the Managing Director for the NC Integrated Care for Kids (NC InCK) Model. Chelsea obtained her Master’s in Public Health at the University of North Carolina at Chapel Hill, where she studied systems and behaviors that drive equitable health care access. Chelsea has worked across a variety of interdisciplinary teams, programs, and projects focused on improving access to and delivery of behavioral health care for families across North Carolina.
Prior to joining Duke-Margolis, Chelsea served as a Program Director for the North Carolina Psychiatry Access Line (NC-PAL) Program and later as the Program Manager of Behavioral Health for the Duke Primary Care Network.
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Opportunities at Duke-Margolis Institute for Health Policy |
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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 with new ones added frequently. Click here to view all of our career opportunities.
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