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In This Issue
Health Policy in Action: Reimbursement for Prescription Digital Therapeutics
Education: SCOHP Case Competition
People: Mark McClellan
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Dev Sangvai Appointed NC DHHS Secretary
Core Faculty Member Devdutta Sangvai has been appointed the new Secretary for the North Carolina Department of Health and Human Services (NC DHHS). Dev is a former Faculty Director of our Margolis Summer Experience program and also has served as President of the Duke Regional Hospital and President of the North Carolina Medical Society. We offer our most sincere congratulations to Dev on this exciting new role and look forward to our continued collaboration with him and NC DHHS. Read the press release here.
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Reimbursement for Prescription Digital Therapeutics
Research Directors Christina Silcox and Beena Bhuiyan Khan, and Senior Policy Analyst Sabine Sussman, co-authored an issue brief that offered policy recommendations to improve the coding and payment processes for prescription digital therapeutics—defined as a software the delivers a medical intervention to treat or manage a disease, disorder, condition, or injury. Read more here.
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Treating Public Health Emergencies
Duke-Margolis researchers Brian Canter, Matt D'Ambrosio, and Rachele Hendricks-Sturrup co-authored a paper in Cambridge University Press that analyzed the lessons learned from using neutralizing monoclonal antibodies (nMAbs) to treat COVID-19 patients. In particular, the authors noted that the strategies used to implement nMAb treatment programs could be used to inform future delivery of novel treatments, and highlighted the need for more public-private partnerships to advance treatment accessibility. Read more here.
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The Path Forward for Accountable Care
As the new Presidential administration sets its health policy agenda, Duke-Margolis researchers Rob Saunders, Rachel Bonesteel, Frank McStay, and Mark McClellan explored potential policy directions to advance accountable care in a Health Affairs Forefront article. In particular, the authors emphasized the need for policies that support clarity and long-term sustainability. Read more here.
This article was featured in AHIP's latest Accountable Care SmartBrief.
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Dual-Eligible Plan Spending
JAMA published an article co-authored by Core Faculty members Megan Shepherd-Banigan, Michelle Franklin, Courtney Van Houtven, Kate Bundorf, and Brystana Kaufman that examined Medicaid spending in coordination-only Dual-Eligible Special Needs Plans. Their findings suggest that dual-eligible Medicaid-Medicare beneficiaries in special needs plans within Medicare Advantage (MA) rather than other MA plans may benefit from increased use of long-term services and supports in their preferred care setting. Read more here.
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Value-Based Payment for Independent Practices
Core Faculty member Mike Pignone, and Duke-Margolis researchers Rachel Bonesteel, Frank McStay, and Rob Saunders, co-authored an article in Family Practice Management that offers guidance for independent practices that seek to transition to value-based payment arrangements. Read more here.
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The Affordable Care Act and Medicare Enrollment
Core Faculty members Virginia Wang, Matt Maciejewski, and Caroline Sloan co-authored a paper in JAMA Health Forum that studied Medicare enrollment and spending among patients undergoing dialysis after the Affordable Care Act. Read their findings here.
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Financial Effects of Bariatric Surgery
Core Faculty members Matt Maciejewski and Caroline Sloan co-authored a paper in the Annals of Internal Medicine to study the health care costs of patients with type 2 diabetes after undergoing bariatric surgery. Duke University School of Medicine reported on the study and quoted Matt in their article—read it here.
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Global Emergency Response and Preparedness
The Duke Global Health Innovation Center’s QuickStart Consortium has published their latest report to support emergency preparedness and response goals for emerging health challenges, such as the ongoing mpox outbreak. The report will be updated and shared every other week with their community—you can subscribe to their newsletter here.
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Artificial Intelligence in Drug Development
The Pharmaletter released an article on the recent FDA draft guidance regarding the usage of artificial intelligence in regulatory decisions to determine if a drug is safe and effective. In this article, they reference the Duke-Margolis event, “Understanding AI/ML in the Drug Development Lifecycle,” that informed the draft guidance.
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SCOPE Summit 2025: Driving Innovation in Clinical Trials and Digital Health
February 2-6, 2025
Location: Rosen Shingle Creek, Orlando, FL (or virtual via Zoom)
Institute Director Mark McClellan will be a keynote speaker at this upcoming summit, presenting on the future of clinical research and the steps required to achieve success. The summit will feature 30 different conferences covering a range of topics, all centered around the opportunities and challenges of advancing clinical operations and trials. Learn more and register here—use code DUKE for $200 off the current rate.
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Your Treatment and Your Community: Advancing Evidence and Policy for Medical Products that Impact Others
March 20, 2025 | 1:00 – 5:00 PM ET
Location: Virtual via Zoom
Because of how easily transmissible many infectious diseases are, individual-level (direct) and population-level (indirect) effects can be conveyed through efforts to prevent, treat, and diagnose infection. Following up on a previous event introducing a policy framework to incorporate population considerations into regulatory and reimbursement pathways, Duke-Margolis will host a workshop to present policy approaches and facilitate discussion on how to better integrate indirect benefits to achieve more comprehensive transmission reduction strategies.
Learn more and register here.
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Scaling Primary Care for High-Need Older Adults: Building a Home-Based Medical Care Ecosystem
The demand for home-based primary care continues to grow, particularly as the ageing population increases. Speakers explored challenges and opportunities to improve support for the health and social care needs of homebound older adults, and discussed learnings from recent research and ways to build on the Centers for Medicare & Medicaid Services' (CMS) advanced primary care efforts. Watch the recording here.
Hea!thcare Innovation reported on the discussions that took place during this event in an article that highlighted the potential of accountable care models to improve home-based care.
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Mortality and Antipsychotic Use in Dementia-Related Behavioral Disorders
Duke-Margolis and the FDA convened a workshop to review data regarding risks associated with the use of medications in the antipsychotic class in older adults with behavioral and psychiatric symptoms associated with dementia. Workshop attendees heard reflections on available evidence and further considerations related to the assessment of risks associated with the use of antipsychotics within this patient population.
Watch the recording here.
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Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products – Looking Forward
Duke-Margolis and the FDA explored recent accomplishments and future activities for the FDA's RWE Program for drugs and biological products. Attendees learned more about the FDA’s approach to RWE for regulatory decision-making, ongoing opportunities and challenges regarding RWE, and future initiatives for promoting the appropriate use of RWE. Watch the recording here.
The FDA’s Center for Clinical Trial Innovation reported on this event in their latest newsletter.
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SCOHP Case Competition
The Student Collaborative on Health Policy (SCOHP) hosts an annual Case Competition that brings in teams of students from Duke University, University of North Carolina at Chapel Hill (UNC), and NC State University to solve a simulated health policy issue. This year’s topic was “Designing a $5 Million Pilot Program to Improve Equitable Access to Mental Health Care and Build Community Resilience in a Selected North Carolina County” and brought in 13 teams with a total of 57 participants. We were thrilled to see so many students showcase their passion for health policy!
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Mark McClellan co-authored a commentary in Health Affairs that identified actions to advance public health in the United States in 2025 and beyond. The commentary was part of a series from the National Academy of Medicine, who will be hosting a virtual briefing next month.
In light of the current H5N1 infections, Mark also co-authored an op-ed in STAT with former FDA commissioner Scott Gottlieb that highlighted the importance of continuing the monitoring programs that are designed to prevent future public health emergencies.
NEJM Catalyst interviewed Mark for a podcast that explored the new administration’s potential impact on health care priorities in 2025 and beyond. Listen or read the transcript here.
Mark also spoke at “The Future of Medicaid Innovation Forum,” an annual event at the JP Morgan Healthcare Conference designed to encourage discussion around advancing high-quality, accessible health care.
Newsweek quoted Mark in an article addressing a recent executive order’s potential impact on prescription drug prices. Read it here.
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Postdoctoral Associate Kun Li co-authored a paper in Medical Care that examined how health system expansion affected Medicare beneficiaries’ use of safety net providers. Read the authors’ findings here. | |
Research Director Rebecca Whitaker spoke at the HealthExecWire’s webinar that discussed the challenges and opportunities for value-based care to advance Medicare. | |
Core Faculty member Mike Pignone was quoted in an article from NBC News that examined the details of a recent study on alcohol consumption and its effects on human health. Read it here. | |
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Rachele Hendricks-Sturrup wrote an article in Health Affairs Forefront that highlighted a new tool designed to help health systems assess their level of trustworthiness and share the actions they are taking to improve patient trust. She also co-authored two other papers:
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Journal of Clinical and Translational Sciences—authors studied patterns in individuals’ willingness to donate data to health researchers after death. Read their findings here.
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JAMIA Network Open—authors explored the lifecycles of AI development and how these cycles might inform ethical analysis of AI. Read more here.
The Evidence Base quoted Rachele in a blog post that discussed potential future developments in real-world evidence in 2025. Read it here.
Rachele also spoke at an event to discuss what community organizations can do to improve reporting, collection, and exchange of race and ethnicity data. This event was part of a series of workshops to advance the Regan-Udall Foundation’s RAISE project.
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NC Health News quoted Christina Silcox in an article about the rise of AI in North Carolina’s health systems and the increasing need for regulation. The Charlotte Post shared this article as well.
Christina also was quoted in The Daily Tar Heel’s article that reported on UNC Hospital’s progress to integrate AI technology into their work. Read it here.
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Kate Bundorf moderated a discussion between Senator Maggie Hassan (D-NH) and former Senator Richard Burr (R-NC) during an event at the Duke in DC office. The speakers focused on bipartisan achievements and opportunities in the current health policy landscape. This event is part of the Duke University Provost's Civil Discourse series. | |
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Core Faculty member Nathan Boucher co-authored a paper in the Journal of the Post-Acute and Long-Term Care Medical Association that collected insights from long-term caregivers in Canada. He also was awarded funding from the Sanford School of Public Policy to research chronic illness and religion in central North Carolina’s Muslim community members.
Nathan also wrote an op-ed in The Hill that discussed the Supreme Court’s review of the Affordable Care Act, noting the benefits and challenges of the preventive-care mandate.
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Patrick Rodriguez is a Policy Analyst on the Biomedical Innovation team and primarily supports projects under the FDA and real-world evidence portfolios. Before joining Duke-Margolis full-time, Patrick was a Junior Policy Analyst at the NIH All of Us Research Program and a summer intern with the Institute. He recently graduated from Duke with an MA in Bioethics and Science Policy with concentrations in both technology and bioscience policy. His experience includes ethical, legal, and social implications of genomics research and policy considerations for emerging neurotechnology and the resulting neural data. While studying at Duke, he was an editorial assistant for the Journal of Law and Biosciences overseen by Duke’s Science and Society program.
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Wenbo Bai is a Senior Policy Analyst on the Health Care Transformation team. Prior to Duke-Margolis, she was a consultant working with life science and industry clients on strategy and policy at Avalere Health. She also worked with Inova Health System's Health Equity Analytics workgroup and with Accountable Care Organizations on population health management at athenahealth. Wenbo has experience with the Centers for Medicare & Medicaid Services’ Quality Payment Programs and Partnership for Quality Measurement processes, claims and real-world data analysis, and social determinants of health policies. A former Fulbright fellow, Wenbo earned a BA in Anthropology and Economics from Wellesley College and an MPH in Health Policy Analysis from George Mason University.
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Molly Shields is a Policy Research Assistant on the Biomedical Innovation team who supports work under FDA grants and the Institute’s collaboration with Highlander Health to optimize clinical research. During her undergraduate career, Molly conducted research on education and HIV policy reforms in New Orleans and has experience working on health policy in the U.S. House of Representatives. Her passion for reducing gender disparities is an underlying theme of her research portfolio. Molly recently graduated from Tulane University with a BA in political science and minors in public health and economics.
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Lauren McCrary is Associate Director of Development at Duke-Margolis. In this role, she works closely with executive leadership at Duke-Margolis, as well as Duke’s Office of Alumni Engagement and Development to advance fundraising for the Institute’s mission and robust portfolio of work. Prior to Duke-Margolis, Lauren had multiple development roles within Duke Health, including Associate Director for Constituency and Pipeline Development at the School of Medicine, as well as Donor Relations within Duke Health. More recently, she was a Client and Community Ambassador for the Adam Dickinson Group at Nest Realty, and Campaign Associate for the Earth Share NC and NC State Employee Combined Campaign. Lauren has strong experience in advancing development, leading gift campaigns, and stewarding the organizations with which she has worked. She earned her BFA in Speech Communication from Valdosta State University in Georgia.
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Audrey Ford is a Policy Research Associate on the Health Care Transformation team and supports projects on the Medicare accountable care portfolio. Audrey has experience in health economics research and health care strategy, previously working as a Research Economist with RTI International, economics instructor at Durham Community College, and Healthcare Strategy Advisor with Blue Cross NC. She earned a BS in Business Administration and Economics from the University of Florida and an MS in Economics from the University of North Carolina at Chapel Hill.
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Opportunities at the Duke-Margolis Institute for Health Policy | |
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. | | | | |