February 2024
In This Issue
Health Policy In Action: Public Health in America
Events: 2024 Health Policy Conference
Education: New Undergraduate Scholars
Health Policy in Action


Value-Based Payment Models for Prescription Drugs

Duke-Margolis researchers Frank McStay, Mark Japinga, Christina Bush, Nitzan Arad, and Rob Saunders released an issue brief that described opportunities to incorporate medications into and align drug pricing reforms with value-based models. Read more here.

The authors also published an accompanying piece in Health Affairs Forefront—read it here.
Addressing Drug Supply Shortages

Duke-Margolis submitted a letter to the U.S. House of Representatives to provide comments and recommendations to address chronic drug shortages. The recommendations focused on three key areas: advancing federal coordination, improving quality management and supply chain reliability, and enabling demand-side reforms for reliability. Read the letter here.
Healthy Opportunities Pilots
Duke-Margolis researchers Katie Huber, Vibhav Nandagiri, Rebecca Whitaker, Yolande Pokam Tchuisseu, Brianna Van Stekelenburg, Andrea Thoumi, Rob Saunders, and Will Bleser co-authored a paper in Health Affairs’ “Housing and Health” issue. The authors explored how health-related housing needs can be addressed at scale through Medicaid, based on lessons from the design and implementation of North Carolina’s Healthy Opportunities Pilots program. Read more here.

Katie also spoke about the paper during Health Affairs’ virtual forum. Watch the recording here.

Home-Based Primary Care

In a new Health Affairs Forefront article, former Margolis Scholar Ginny Rogers and Duke-Margolis researchers Montgomery Smith, Jonathan Gonzalez-Smith, and Rob Saunders explored opportunities to redesign care models given the unique needs of rural communities and policy and payment reforms to scale home-based primary care access. Read more here.



Tricuspid Valve Interventions

A Duke-Margolis report discussed findings from a roundtable series, co-hosted by the Heart Valve Collaboratory, on the coverage and evidence needs for emerging tricuspid valve interventions. The report discussed the value of multi-stakeholder engagement for informing post-market evidence generation strategies to support coverage, patient access, and uptake of novel medical products. Read more here.



Public Health in America

The National Academy of Medicine and Duke-Margolis co-published an issue brief, “Collaborative Short-Term Action to Advance America’s Health,” that outlined policy recommendations to address major public health issues in the United States. The issue brief was discussed during a related event to spark broader conversation about the future of America’s health.
Hepatitis C Elimination

Duke-Margolis released the final updates to a project report, “Advancing Hepatitis C Elimination: Implementation Strategy for the Proposed National Program.” The report included a strategic framework for a national hepatitis C elimination program with the goal of informing an implementation pathway for the Biden Administration’s existing proposal.

Read more about the Duke-Margolis hepatitis C elimination project here.
Policy Impact
Real-World Evidence (RWE) and Real-World Data (RWD)

Regulatory Focus summarized the discussion at a recent event co-hosted by the Friends of Cancer, Aetion, and Duke-Margolis: "Advancing Real-World Data to Generate Regulatory Grade Real-World Evidence in Oncology." Mark McClellan was the keynote speaker and highlighted the need for alignment on defining real-world evidence (RWE) and real-world data (RWD). Research Director Rachele Hendricks-Sturrup also moderated a panel on patient-centered RWD. Read the article here.

Clinical Trial Innovation

The Pink Sheet reported on the conversations that arose at the Duke-Margolis event, “Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches.” The article emphasized the need for cross-disciplinary thinking and the adoption of a quality mentality to improve clinical trial design. Read more here.

Clinical Leader also covered this event and, in addition to summarizing the main points, noted the recommendations for the industry to modernize clinical trial approaches and that someone must lead the charge to encourage others to improve their own study design and conduct. Read the article here.
Upcoming Events
Enhancing Adoption of Innovative Clinical Trial Approaches

March 19, 2024 | 10:00am-5:00pm ET
March 20, 2024 | 12:30-5:00pm ET

In-Person Location: Kellogg Conference Hotel, Washington, DC

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 Food and Drug Administration (FDA) to discuss the considerations and opportunities surrounding clinical trial innovation.

Learn more and register here.
Fostering Collaboration to Advance Representative Enrollment in Clinical Trials

March 28, 2024 | 10:00am-2:45pm ET

Collaboration among stakeholders can increase representativeness in clinical trials. Learn more about the best ways to build collaboration, establish long-term community engagement, incentivize trial representation, and scale innovative trial infrastructures in this upcoming virtual meeting.

Register here.

Updating Health Reform for the Next Decade: Key Challenges and New Opportunities

April 11, 2024 | 12:00-5:00 pm ET

In-Person Location: Westin Washington, DC Downtown

Join us for the Duke-Margolis 2024 Health Policy Conference! In this hybrid event held in-person in Washington, DC, 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 a range of the most pressing challenges facing America’s health, and will feature elected and appointed officials, academics, private sector leaders, and patient advocates.

Learn more and register here.

Past Events
Collaborative Short-Term Action to Advance America's Health

The National Academy of Medicine and Duke-Margolis hosted a webinar to discuss collaborative short-term actions that could be taken to advance America’s health, and to explore emerging comprehensive strategies for public health and health care to seed further progress in 2025 and beyond.

Learn more here.

Education
New Undergraduate Scholars

Our Margolis Scholars program selects a few passionate undergraduate and graduate students each year to study health policy at Duke-Margolis. Scholars spend one to two years working with faculty and staff to develop the research and leadership skills necessary for a career in health policy. We are thrilled to welcome four new undergraduate Scholars who will join us this fall semester:
Olivia Kim (’26) is majoring in biology and pursuing a health policy certificate at Trinity College. As a Margolis Scholar, Olivia is particularly focused on health policy initiatives that aim to improve care access and quality for the Intellectually and Developmentally Disabled (IDD) community and other marginalized groups. In the future, Olivia hopes to combine her practice of medicine with ongoing work in health policy and advocacy, with a continued emphasis on creating more inclusive and equitable health care systems.

Pranav Mukund (’26) is majoring in biomedical engineering at the Pratt School of Engineering. As a research assistant in the David Lab, he is working to develop medical devices that improve nurse safety, patient health, and data collection practices in hospital settings. Additionally, Pranav works closely with Duke Wellness to promote and implement drug overdose education at Duke. In the future, he plans to pursue a career in medicine and use his clinical insights to guide the development of medical devices. Pranav looks forward to learning more about regulatory policy, health technology assessment, and innovation incentives through the Duke-Margolis Scholars program.

Aubteen Pour-Biazar (’26) is studying Public Policy and Economics at Trinity College and is interested in the intersection of science and policy, and using evidence-based research to inform public policy decisions. A former Margolis Intern, Aubteen is working on a research project investigating the notice-and-comment rulemaking process for federal health regulations with Kate Bundorf. As a Margolis Scholar, Aubteen hopes to delve deeper into his health policy interests and explore the connection between policy and health care. 

Ananya Sridhar (’26) is working towards a Biomedical Engineering degree at the Pratt School of Engineering while pursuing a Certificate in Health Policy. Through the Margolis Scholar program, Ananya aims to bridge the gap between biomedical engineering and health policy, with a focus on bioethics. She looks forward to learning from and collaborating with the Margolis Center faculty and her fellow scholars, expanding her understanding of the health care ecosystem, and developing the skills to nurture her passion for ethical considerations in engineering and health policy.
People


Senior Policy Analyst Katie Huber spoke about Duke-Margolis’s research surrounding the Pilots with students involved in the Duke Student Collaborative on Health Policy and the Duke Help Desk, a student-run volunteer program that connects patients with community resources. She discussed the program’s history and gave advice on how to design a study and write for a policy audience.

Core Faculty member Frank Wharam co-authored a paper in JAMA Health Forum, “Acute Diabetes Complications After Transition to a Value-Based Medication Benefit,” that studied the short-term health impact of value-based medication benefits on patients with diabetes. 

Alignment Health interviewed Mark McClellan for their series, “Servant Leadership at Work,” where Mark discussed his history in medicine and public service, as well as his current work at Duke-Margolis. Read his story here.

Core Faculty member Brystana Kaufman co-authored “GUIDE dementia model: Opportunities for serious illness care,” a paper in the Journal of the American Geriatrics Society that analyzed the new Medicare payment model for dementia care and implications for the future of serious illness care.


Area Lead Andrea Thoumi and former Policy Analyst Kamaria Kaalund received the MaryAnn Black Health Equity Impact Award for their poster, “Naming and Framing: Six Principles for Embedding Health Equity Language in Policy Research, Writing, and Practice,” during a research symposium held by the Duke Cancer Institute. 
Core Faculty member Courtney Van Houtven co-authored a paper in Social Science & Medicine that assessed the effect of caregiving from adult children on Veterans Affairs utilization and expenditures, and noted that caregiver stipend payments may be offset by decreased health care utilization.

Research Director Rachele Hendricks-Sturrup was a panelist at the Duke Law School’s event, “Beyond the Reach of HIPAA: Mental Health Apps, Health Data, and Privacy,” and discussed the urgent need for policy to regulate the commercial collection and use of health data. Read the Duke Today article here.

Core Faculty member David Ridley co-authored a paper in BMJ Global Health that found the Priority Review Voucher program in the European Union would substantially increase the reward for product development for otherwise neglected diseases. 

Team Member Welcome
Camryn Lemke has joined Duke-Margolis as an Administrative Assistant. Camryn earned her Bachelor’s degree in Social Policy and Global Health at Northwestern University. Prior to joining Duke-Margolis, she worked for a variety of non-profit organization—most recently, in eviction defense services and community-driven K-12 education partnerships. Camryn brings her organizational prowess and passion for health equity to Duke-Margolis to support the executive team and enable the education and research teams to succeed in their mission.