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In This Issue
Health Policy in Action: Tariffs on Pharmaceuticals
Policy Impact: Duke Research Saves Lives
Upcoming Events: Lessons Learned from the CDRP Program
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Duke-Margolis Launches Capital Impact Council
The Duke-Margolis Capital Impact Council (CIC) supports the development of strategies, tools, and frameworks to enable the private investment community to demonstrate and deliver measurable benefits for health outcomes, access, affordability, and community resilience.
Co-chaired by FlyteHealth Executive Chair Cheryl Pegus and Duke-Margolis Director Mark McClellan, the CIC is comprised of mission-aligned venture capital and private equity investors and Duke-Margolis Advisory Board members. The council is dedicated to:
- advancing use of evidence and establishing best practices for achieving measurable health value improvements through private investment in health care.
- driving the impact of private investment in health care to improve the lives of people and communities.
The CIC released its initial resource, a framework designed to align health system and investor incentives around private investment that improves health care and health. The paper—“Health Value Return on Investment (HV-ROI): A Framework to Support Private Investment that Improves Health Care and Health”—includes examples from council members of the council that demonstrate application of the framework to establish a community of practice and collaboration to advance this goal.
The HV-ROI framework includes two key elements:
- HV Model and Evidence: A baseline analysis of the positive impact of a proposed investment on health value as well as its potential financial ROI, based on published literature and preliminary evidence.
- HV Key Performance Indicators: Feasible and worthwhile metrics linked to the model that will be tracked and updated, enabling an organization to be proactive in advancing health value alongside financial ROI.
Fierce Healthcare and PR Newswire covered the CIC launch and accompanying framework document. More information on the Capital Impact Council can be found on the Duke-Margolis website as well as in the Capital Impact Council Fact Sheet.
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New Visiting Fellow
William Shrank joins Duke-Margolis as a Visiting Fellow, who participate in working groups and activities that support research on a variety of health policy research initiatives. Specifically, Will will work with the Duke-Margolis team to advance West Health-funded project focused on Medicare policy and learning hubs. Will is currently a venture partner to the Bio + Health team of Andreessen Horowitz, a private venture capital firm, and is a member of the Walgreens Boots Alliance’s Board of Directors. He previously served as Chief Medical Officer of Humana Inc., where he implemented their integrated health care delivery strategy with an emphasis on advancing the company’s clinical capabilities and core objective of improving the health outcomes of its members. He also worked with the University of Pittsburg Medical Center and CVS Health, and was Director of the Research and Rapid-Cycle Evaluation Group at the Center for Medicare and Medicaid Innovation.
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Reducing Viral Disease Transmission
Duke-Margolis has released two white papers to investigate ways to reduce viral disease transmission through indirect, population-level benefits:
"Supporting Evidence Generation of Indirect Benefits and Risks for Medical Products Used for Infectious Diseases" provided an overview of evidence sources on indirect benefits, and proposes policy recommendations on how to generate and leverage better evidence. Read it here.
"Integrating Indirect Health Benefits into Biomedical Policy: Key Reforms for Federal Agencies to Reduce Disease Transmission" identified ways to incorporate indirect benefits into regulatory and reimbursement processes. Read it here.
These papers were discussed during a Duke-Margolis public workshop—learn more and watch the recording here.
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Tariffs on Pharmaceuticals
Duke-Margolis researchers Thomas Roades, Stephen Colvill, and Mark McClellan co-authored an article in Health Affairs Forefront, which described the potential impact of tariffs on the pharmaceutical supply chain and drug prices. The authors also proposed how vulnerability assessments should be performed on critical pharmaceutical product categories to determine the best policy options to achieve desired outcomes. Read the article here.
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NC State Transformation Collaborative
With support from the NC Department of Health and Human Services, Duke-Margolis hosted a Health Care Transformation Workgroup meeting with the goal of advancing the NC State Transformation Collaborative (STC)’s efforts to transform health care in the state through multi-stakeholder alignment in value-based care strategies. Specifically, the Workgroup met to discuss evaluation approaches and implementation steps for the NC State Transformation Collaborative Alignment Proposal.
For more information about the NC STC, subscribe to their newsletter. And save the date for the NC STC’s annual public meeting on June 24, 2025, held on Duke campus!
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Guidance on Study Protocols
Duke-Margolis submitted a comment letter in response to the Centers for Medicare & Medicaid Services' (CMS) proposed guidance document on “Study Protocols that Use Real-World Data.” The comment letter offered recommendations for clarifying protocol updates and how the new HARPER+ framework may be applied, and outlined future action steps for consideration. Read more here.
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Duke Research Saves Lives
Duke University has launched a campaign, “Duke Research Saves Lives,” to highlight the important work being done to revolutionize research for surgery, cancer, neuroscience, veterans’ care, and more. The campaign celebrates the real-world stories of lives changed by Duke research and will continue to collect these stories. Please visit the campaign webpage often for regular updates!
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2025 Health Policy Conference: Evolving Better Health Care for Every American
May 13, 2025 | 12:30 – 5:00 pm ET
Location: Westin Washington DC Downtown (or virtual via Zoom)
Join us for the 2025 Duke-Margolis Health Policy Conference. We will bring together leading policy makers and experts from across the public health and health care sectors for an afternoon of timely keynotes and panel discussions. These discussions will focus on efforts make health care better and more affordable for Americans. The conference will feature elected and appointed officials, academics, private sector leaders, and patient advocates.
Learn more and register here.
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Lessons Learned from the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program
May 20, 2025 | 1:00 – 4:45 pm ET
Location: Virtual via Zoom
In collaboration with U.S. Food and Drug Administration (FDA), Duke-Margolis will host a workshop that will delve into the challenges and strategies for expedited chemistry, manufacturing, and controls development. The meeting will feature perspectives from both industry leaders and FDA regulators, who will discuss best practices and lessons learned from the pilot program.
Learn more and register here.
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Bipartisan Innovation in Action: The Role of North Carolina’s Healthy Opportunities Pilots in Advancing Whole-Person, Cost-Effective Care
During this webinar, speakers discussed the positive impact of North Carolina’s Healthy Opportunities Pilots program on health, well-being, and local economies in communities across the state. The Pilots are a promising model for bipartisan health reform, offering valuable lessons for policymakers, payers, health care providers, and community leaders in North Carolina and beyond. Watch the recording here.
NC Newsline reported on this event—read the article here.
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The Future of Accountable Care: Potential Paths to Making "Alternative" Payment Models the Norm
Five years after CMS set their ambitious 2030 accountable care goals, the broader accountable care landscape is at a potential inflection point. As growth in accountable care programs in Traditional Medicare continues and the majority of Medicare beneficiaries are now in Medicare Advantage plans, questions about the future and sustainability of accountable care models are emerging amidst the backdrop of priorities being set by the new presidential administration. During this webinar, leading experts discussed federal policy opportunities and priorities to transform the health system. Watch the recording here.
Hea!thcare Innovation covered this event in an article focused on how health systems should discuss value-based care with patients.
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Your Treatment and Your Community: Advancing Evidence and Policy for Medical Products that Impact Others
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 hosted a virtual workshop to present policy approaches and facilitate discussion on how to better integrate indirect benefits to achieve more comprehensive transmission reduction strategies. Watch the recording here.
AgencyIQ, Endpoints News, Pink Sheet, and CBS News reported on this event, particularly focusing on comments from Peter Marks, FDA Director of the Center for Biologics Evaluation and Research.
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Core Faculty member Matt Maciejewski co-authored two papers in the Journal of the American Geriatrics Society, both of which investigated how to support studies of deprescribing (stopping or reducing risky or unneeded medications) using more effective data collection and use:
Matt also co-authored a paper in the Annals of Internal Medicine that analyzed the health expenditures of patients with diabetes after bariatric surgery. They found that, post-surgery, overall expenditures decreased substantially—read more here.
| | Research Director Rachele Hendricks-Sturrup, along with former Duke-Margolis researchers Caleigh Propes and Trevan Locke, co-authored a paper in Learning Health Systems that examined the landscape of informed consent practices and challenges in point-of-care clinical trials. Read it here. | | Core Faculty member Charlene Wong was a keynote speaker at the 2025 Duke MBA Health Care Conference that explored challenges and opportunities to advance health care access for all. Learn more here. | | Postdoctoral Associate Kun Li was selected as an editorial board member of the Journal of Ambulatory Care Management to advance the journal’s mission of “promoting health equity in communities and systems of care through timely, peer-reviewed, practice-informed scholarship.” Congratulations, Kun! | | |
Mark McClellan joined an episode Yale University’s Health & Veritas podcast series, where he spoke about his career and shared his insights on the intersection of health, economics, and policy. Listen to the podcast here.
Roll Call quoted Mark in an article discussing the proposed cuts to the user fee program that pharmaceutical developers use to pay the FDA in exchange for reviewing their product applications. The loss of this funding, Mark noted, may result in slower approval times. Read more here.
| | Deputy Director Gillian Sanders Schmidler is part of the Health Economics Methods Advisory Group, which has just announced its first research topic. With her fellow group members, Gillian will assess the benefits of treatment that are appropriate to consider in health technology assessment (HTA) decision-making. Specifically, researchers will develop guidance for HTA organizations on the principles for identifying potential new benefits to include in economic studies, how to implement any changes to benefits, and any measurement challenges that may exist. | | |
Senior Research Director Rob Saunders, former intern Olivia Mitchell, and former Duke-Margolis researcher Jonathan Gonzalez-Smith co-authored a blog post in Health Affairs Forefront that reviewed recent Medicaid care policies and offered recommended next steps for State Directed Payments and Medical Loss Ratio reporting as Medicaid’s policies continue to evolve. Read more here.
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Core Faculty member David Ridley spoke at the Rare Disease Company Coalition’s Congressional briefing, “Rare Diseases, Common Sense Solutions: How Policy Can Empower Progress.” In particular, David discussed the priority review voucher program, which is designed to incentivize new drug development.
| | Core Faculty member Nathan Boucher wrote an op-ed in The Fayetteville Observer that discussed the potential impact of proposed federal spending cuts on Medicaid and noted the importance of Medicaid in North Carolina, particularly for the health of rural populations. Read more here. | | |
As Administrative Assistant to the Director, Sevy Buchan will provide administrative support to Duke-Margolis. Sevy has over 35 years of experience providing administrative support to the government intelligence community, civilian agencies, university departments, and medical organizations. Prior to Duke-Margolis, Sevy was most recently Administrative Assistant at the Catholic University of America Columbus School of Law. She also has worked with many academic health organizations and governmental departments, including George Washington University’s School of Medicine and Health Sciences, Johns Hopkins Bayview Medical Center, Maryland’s Department of Health & Mental Hygiene—Office of Health Care Quality, Virginia’s Department of Health, U.S. Embassies in Lithuania and Indonesia, and more. Sevy earned her BA in Business Administration from the Secretarial Academy of Indonesia.
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Valerie Lehman joins Duke-Margolis as an Assistant Research Director on the Health Care Transformation team and manages the rapid learning portfolio. Prior to Duke-Margolis, she was most recently a Program Officer who oversaw funded dissemination and implementation projects and the launch of a large health systems-focused implementation initiative at the Patient-Centered Outcomes Research Institute. Val also held several operational roles managing palliative care services as well as an oncology and hematology clinic at the Luminis Health Anne Arundel Medical Center, worked at the National Academy of Medicine, and was a Health Policy Fellow working with former U.S. Representative John P. Sarbanes. She earned her BA in International Politics from Pennsylvania State University and her MHA from George Washington University.
| | 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. | | | | |
