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In This Issue
Health Policy in Action: HHS Should Establish a Prevent Drug Shortages Initiative
Upcoming Events: Advancing Health Priorities that Matter to the IDD Community
People: Rushina Cholera and Chelsea Swanson
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2025 Health Policy Conference Highlights
At its fourth annual national conference, Duke-Margolis brought more than 1,700 members of health policy community together, in-person and virtually, for in-depth discussions on a host of leading topics—from the new Centers for Medicare & Medicaid Services innovation strategy and caring for underserved populations to strengthening the drug supply chain, public-private partnerships and investment to advance health, and scaling AI in health care so it works for patients. Read highlights of the conference here and a sample of the news coverage of the event in McKnights, MedPage Today, and Fierce Healthcare.
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Duke-Margolis Submits Public Comment on Section 232 Pharmaceutical Manufacturing Policy
Duke-Margolis researchers Stephen Colvill, Thomas Roades, Madi Cordle, and Mark McClellan submitted a public comment letter addressing the U.S. Department of Commerce’s Section 232 investigation into pharmaceutical manufacturing. The letter emphasizes the need to align policy tools—such as tax incentives, reimbursement reform, and domestic investment—with specific geopolitical and supply chain goals, while cautioning against broad pharmaceutical tariffs that could harm patient access and exacerbate drug shortages. The authors advocate for a targeted, evidence-based approach and highlight the importance of vulnerability assessments and strategic policy alignment to strengthen domestic manufacturing without unintended consequences. Read the letter here.
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HHS Should Establish a Prevent Drug Shortages Initiative
Preventing drug shortages is a complex challenge that no one federal agency can tackle on its own. In a new issue brief, Duke-Margolis authors Stephen Colvill and Thomas Roades recommend that the U.S. Department of Health and Human Services (HHS) create a Prevent Drug Shortages Initiative to create and execute a coordinated, proactive strategy to improve the reliability of the drug supply chain. Read the issue brief here.
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Duke-Margolis Shares Research at Highlander Health Institute Summit
Duke-Margolis joined other health innovation leaders at the Inaugural Highlander Health Institute Summit, presenting early findings and a strategic vision for strengthening clinical evidence generation. Mark McClellan, Marianne Hamilton Lopez, and Brian Canter participated in the Summit, with core research contributions from Patrick Rodriguez and Molly Shields. The team is finalizing policy recommendations for a longitudinal learning system designed to generate patient-centered evidence, informed by real-world data strategies that enhance collection, linkage, and comprehensive patient insights.
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Advancing Health Priorities that Matter to the IDD Community: Learnings and Future Directions
June 10, 2025 | 4:00 pm – 5:00 pm ET
Location: Virtual via Zoom
Days in the community, or “home time,” is considered a patient-centered outcome measure reflecting clinical events that impact quality of life and patient preferences. However, it is also important to consider whether someone lives in their home of choice and has what they need to be healthy and safe. Including perspectives of the intellectual and other developmental disabilities (IDD) community is essential to understanding how the concept of “home” and "home time" aligns with health priorities, particularly as they age. This webinar will share learnings from the IDD community about health outcomes that matter to them and feature a panel with state and disability experts to explore opportunities to center the voices of the disability community in policy and co-create patient-centered outcome measures.
Learn more and register heree.
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Prioritizing Community Voices to Enhance Medicaid Policy and Program Design
June 12, 2025 | 2:00 pm – 3:00 pm ET
Location: Virtual via Zoom
Value-based payment (VBP) has the potential to tailor health and social care to address Medicaid members' unique needs through flexibilities granted to Medicaid providers. To ensure VBP delivers on this potential and promotes efficient and effective use of Medicaid dollars, we need to understand what people want and need to be healthy and ensure we have enough providers to meet those needs, particularly in rural and medically underserved areas.
During this webinar, panelists representing state and federal perspectives on Medicaid policymaking and community engagement will discuss strategies that can help center the community member voice within Medicaid VBP design, implementation, and oversight to advance community health and well-being.
Learn more and register here.
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Advancing Whole-Person Health Care For All Through North Carolina’s State Transformation Collaborative
June 24, 2025 | 2:00 pm – 5:00 pm ET
Location: Duke University and Virtual via Zoom
Join Duke-Margolis in a few weeks as we gather health policy leaders to discuss the progress of the NC State Transformation Collaborative (NC STC) on advancing value-based primary care and reducing provider burden in North Carolina. In February 2023, the North Carolina State Transformation Collaborative (NC STC) was launched to promote high-value and whole-person care through multistakeholder partnerships. NC is one of four states participating in the STC initiative, initially launched by the Health Care Payment Learning and Action Network (HCP-LAN) and the Centers for Medicare & Medicaid Services (CMS). In NC, the STC is financially supported by the NC Department of Health and Human Services (NCDHHS) with Duke-Margolis serving as the neutral convener.
Learn more and register here.
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New Directions for Accountable Care: Understanding Opportunities Within CMMI’s Updated Strategy
Duke-Margolis, in partnership with West Health, hosted a webinar to discuss the major head and tail winds of accountable care and health system transformation that the Center for Medicare and Medicaid Innovation (CMMI) is contending with. Speakers discussed the new directions which CMMI is taking, including key priorities and areas of progress, challenges, and opportunities going forward in an evolving health care landscape.
Watch the recording here.
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Generic Drug Repurposing: Exploring the Potential Role of the Regulator and Policy Solutions
This hybrid workshop discussed the potential role of the regulator as it relates to generic drug repurposing. Discussion explored a range of proposed solutions that aim to address challenges in identifying drug repurposing opportunities, seeking label expansion by nontraditional developers, and updating labels to encourage responsible drug promotion and public health benefit. This workshop identified priority recommendations and opportunities to address key regulatory challenges and help to unlock the full potential of generic drugs.
Regulatory Focus reported on this event here.
Watch the recording here.
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End-of-Year Celebration
Students and their families visited the Duke-Margolis office in Durham to celebrate the end of the academic year. Founding Donor Bob Margolis, Mark McClellan, Gillian Sanders Schmidler, Kate Bundorf, and Beth Gifford offered remarks to celebrate the students’ accomplishments and encourage this next generation of health policy leaders to continue their good work. Congratulations to the Class of 2025!
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In an interview published in Health Affairs Scholar, Mark McClellan discussed Medicare Advantage (MA) reform. In particular, he noted the need for reforms and legislation to address the challenges for both MA and Traditional Medicare as the former rapidly grows. Read more here.
Mark co-authored an article in JAMA Health Forum with Scott Gottlieb to share feedback on the proposed restructuring of the U.S. Food and Drug Administration (FDA). They offer suggestions on how the plan could be adjusted to help the FDA maintain their efficacy in the face of downsizing—read more here.
Cheryl Pegus, Co-Chair of the Duke-Margolis Capital Impact Council, and Mark explored the relationship between health care funding and patient outcomes in the American College of Healthcare Executives’ (ACHE) Healthcare Executive podcast. In particular, they discussed how private sector investment can support funding and enhance health care delivery, a topic they also covered at the ACHE 2025 Congress on Healthcare Leadership and our 2025 Health Policy Conference. Listen to the podcast here.
| | WRAL quoted Core Faculty member Adrian Hernandez in an article that discussed North Carolina’s bill to expand access to the antiparasitic drug ivermectin for human patients and offer liability protection to doctors that dispense it. Adrian noted that no large-scale studies have shown ivermectin as effective against COVID-19 or other common diseases in the U.S. Read the article here. | | Core Faculty member Megan Shepherd-Banigan co-authored a paper in the International Journal of Care and Caring, which studied family caregivers’ experiences of caring for adults or children with a serious illness. The authors noted five major themes that largely centered on the complexity of a caregiver’s role and the stress it puts on the caregiver long-term. Read more here. | | Stephen Colvill participated in the CPHI Americas Conference, serving as a panelist in the session titled, “Futureproofing U.S. Pharma: Strengthening Supply Chains to Tackle Emerging Challenges.” The discussion explored strategies for building more resilient pharmaceutical supply chains in response to evolving global demands and disruptions. Stephen shared insights on policy and market-based solutions to ensure stability and responsiveness in the U.S. pharmaceutical sector. Learn more | | |
Christina Silcox co-authored two recent publications advancing the responsible use of AI in health care. “Algorithm-Based Clinical Decision Support: Evolving Regulatory Landscape and Best Practices for Local Oversight,” explores the regulatory environment and oversight strategies for health systems implementing AI-driven clinical tools. The authors reviewed the regulatory decisions and governance frameworks surrounding CDS systems, best practices for implementation, and avenues for future innovation. Read the paper here.
In “Building Competency in Artificial Intelligence and Bias Mitigation for Nurse Scientists and Aligned Health Researchers,” Silcox and colleagues introduce the HUMAINE training program—developed at Duke—to equip clinicians and researchers with the skills needed to use AI and/or machine learningML in ways that advance health equity. Read that paper here.
| | In a recent New England Journal of Medicine article, Core Faculty member Peter Ubel and colleagues examine the complex legal and ethical terrain health care professionals face as immigration enforcement evolves. Quoted in Duke Daily, Peter emphasized, “Health care professionals may face legal and ethical challenges as immigration policies evolve. By understanding their own legal rights and those of their patients, they can continue caring for patients while advocating for them and adhering to the law.” Read the article here. | | |
Beth Boyer represented Duke-Margolis at the International Drug Repurposing Conference in Amsterdam, where she presented a proposal for a pull incentive to support generic drug repurposing. The proposal, developed in collaboration with the University of Chicago's Market Shaping Accelerator, outlines a strategy to encourage investment in repurposing efforts through sustainable market incentives. Boyer also participated in a panel discussion focused on building viable business models to advance drug repurposing initiatives. More here.
| | Nathan Boucher, Duke-Margolis Core Faculty member, published a new peer-reviewed policy paper in PEC Innovations examining the role of Community Health Workers (CHWs) in home and community-based services for American Indian and Alaska Native populations. The paper underscores how CHWs improve health outcomes through culturally informed care while facing systemic barriers to full integration. Nathan’s findings support expanded use of CHWs, noting the importance of state certification, training, and reimbursement in strengthening this vital workforce and enhancing community-based care delivery. Read the article here. | | |
Congratulations to former Margolis Scholar Jay Lusk, MD, MBA, and Duke-Margolis core faculty members Brystana Kaufman and Emily O'Brien on their recent publication in BMJ. The study finds that while fewer patients are being newly diagnosed with dementia in routine clinical practice, the overall number of people living with dementia continues to grow. These findings highlight the evolving landscape of dementia care and underscore the importance of long-term support strategies. Read the full article.
Core Faculty member Brystana Kaufman also co-authored a new publication in the Archives of Physical Medicine and Rehabilitation highlighting the critical role of family caregivers in supporting patients with rehabilitation and chronic care needs. The article discusses the historical lack of training support for caregivers outside inpatient settings due to limited reimbursement and introduces newly approved Centers for Medicare & Medicaid Services codes that create opportunities for expanded caregiver training. The authors outline potential practice improvements and research pathways to evaluate the impact of these policies on both patient and caregiver outcomes. Read the full article here.
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Rachele Hendricks-Sturrup, alongside Nora Emmott and Maryam Nafie of the Real World Evidence team, co-authored article published in the Journal of Clinical and Translational Sciences titled “Opportunities amid complexities in returning genetic results to Black precision medicine research participants.” The study was supported by the NIH All of Us Research Program and explores insights from participant interviews within the Open All of Us dataset.
Rachele also presented at ISPOR 2025, discussing approaches to personalizing race and ethnicity data to enhance the relevance and reliability of real-world evidence. Additionally, she presented the RWE Collaborative’s white paper, “Real-World Evidence to Support Causal Inference,” during the PHUSE 2025 Real-World Evidence Webinar Series, focusing on methodological considerations for non-interventional studies.
| | Core Faculty member Rushina Cholera and Assistant Research Director Chelsea Swanson have been awarded funding from The Duke Endowment to assess the effectiveness of North Carolina’s Integrated Care for Kids model. Their evaluation will focus on how well the model identifies and addresses risks of out-of-home placement among Medicaid-insured children, contributing valuable insights into the impact of integrated care on child and family well-being. | | 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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