In This Issue

Health Policy in Action: Value-Based Payment in Medicaid

Policy Matters: Duke-Margolis Strongly Represented at AcademyHealth

People: Rushina Cholera



Real-World Evidence to Support Causal Inference

Duke-Margolis has released a white paper to offer guidance on how real-world evidence (RWE) may be used to strengthen clinical data gathered through non-interventional studies, which play a crucial role in assessing treatment effects beyond the confines of traditional randomized clinical trials. Promoting RWE’s capacity for causal inference is essential for advancing evidence-based health care. Read more here.

Addressing Drug Shortages

In consultation with the ReVAMP Drug Supply Chain Consortium, Duke-Margolis has released a comment letter that offers recommendations to enhance the Senate Finance Committee’s recently proposed approach to prevent drug shortages. Read more here.



Value-Based Payment in Medicaid

Duke-Margolis researchers Beena Bhuiyan Khan, Victoria Gemme, Aparna Higgins, and Corinna Sorenson co-authored an article published in The Milbank Quarterly to analyze Medicaid agencies’ value-based payment arrangements for medical products and offer policy recommendations to support them. Read the paper here.

Data Infrastructure to Advance Public Health

Policy Analyst Matt D'Ambrosio, Assistant Research Director Trevan Locke, and Research Director Rachele Hendricks-Sturrup published a commentary in the Journal of Public Health Management and Practice. They discussed the One Health response to Lyme disease in the state of New Jersey and offered policy recommendations for strengthening health system and public health data infrastructures for climate-driven changes to infectious disease. Read more here.

Opioid Settlement Funds

Duke-Margolis has released an Opioid Measurement Toolkit to guide stakeholders on how to spend opioid settlement funds effectively. These funds offer a short-term opportunity to invest in improvements to the behavioral health system, but long-term sustainability of investments once settlement funds cease is a concern. Read our researchers’ recommendations here.

Assessing Value in Biomedical Innovation

Senior Research Director Marianne Hamilton-Lopez and Director Mark McClellan co-authored an editorial in Value in Health that explores opportunities to improve value assessment of new medical technologies, using the recent ISPOR Good Practices report as guidance. Read more here.

A Value Proposition for Pharmacogenetic Testing

Core Faculty members Nina Sperber and Brystana Kaufman co-authored a paper in Clinical and Translational Science to explore a value proposition for health systems using pharmacogenetic testing for mental health medications. Recommendations centered on integrating pharmacogenetic testing into primary care and supporting prescribers’ interactions with patients. Read more here.

Duke-Margolis Strongly Represented at AcademyHealth

AcademyHealth's 2024 Annual Research Meeting featured panels and presentations from a number of Duke-Margolis researchers, faculty, and students, who showcased recent and upcoming work across the Institute's health policy portfolio. The conference is designed to convene researchers in health, health care, and policy to share their work with a broader audience.

Research Director Will Bleser moderated a policy roundtable, “First Year Policy & Implementation Lessons from New Equity-Focused Value-Based Models,” and presented during a panel session, “Advancements in Health Equity: Alternate Payment Models and the Health Care Payment and Learning Network (HCPLAN).”

Assistant Research Director Jonathan Gonzalez-Smith moderated a policy roundtable, “Ensuring a Longitudinal Care Experience for Older Adults Enrolled in Medicare Advantage.”

Area Lead Andrea Thoumi moderated a session, “Best of ARM: Policy and Economic Implications,” and presented during a panel session, “Overlooked Partners in Health: Engaging Community in Research and How It’s Done.”

Former Margolis Scholar and Health Policy Certificate Graduate Nikhil Chaudhry (’24) presented a poster on “Community-Centered Solutions to Increase Insurance Enrollment Among La Comunidad Latina in North Carolina.”

Former Margolis Scholar Natalie Wong (’24) presented a poster on “Evaluating Medicaid Expansion: A Synthesis of State Based Approaches and Implications for North Carolina.”



Brystana Kaufman moderated a session, “Late-Breaking Session – Data Blitz: Policy and Quality of Care,” and presented a poster on “The Relationship between Care Coordination in Medicare Special Needs Plans and Medicaid Spending: A North Carolina Case Study.”

Postdoctoral Associate Kun Li presented posters on:

• “Association between Medicaid Comprehensive Risk-Based Managed Care and Medicaid Advantage Penetration”
• “Vertical Integration and Medicare Beneficiaries at Federally Qualified Health Centers”
• “Association between Value-Based Payments in Medicare and Preventive Service Utilization Among Commercially Insured Adults”

Kun also presented on “Participation of Federally Qualified Health Centers and Performance of Medicare Shared Savings Program Accountable Care Organizations” as part of a panel session, “The Impact of Ownership and Affiliation Structures on Cost and Quality Outcomes.”

Senior Policy Analyst Montgomery Smith presented a poster on “Policy Opportunities to Improve Care in the Safety Net through Value-Based Payment Reform."

Postdoctoral Associate Sandra Yankah presented a poster on “Revitalizing the SUD Systems: Opioid Settlement Funds As a Catalyst for Change.”

Senior Policy Analyst Katie Huber presented on the lessons learned from the Healthy Opportunity Pilots program as part of a panel session, “Social Needs, Healthcare Utilization and Medicaid.” 

Clinical Trial Innovation

Trevan Locke was recently a panelist at the 2024 Biotechnology Innovation Organization (BIO) International Convention, and BIO News has published an article to report on that panel’s discussion of clinical trial diversity. The article also referenced a 2022 Duke-Margolis white paper that noted the promise of point-of-care trials. Read more here.

North Carolina State Transformation Collaborative

Duke-Margolis hosted its quarterly NC Health Care Reform Executive Roundtable Meeting with health care, foundation, and executive leaders to share updates and progress on the North Carolina State Transformation Collaborative’s Alignment Proposal and gather strategic feedback from attendees on action steps. 

To learn more about the NC State Transformation Collaborative (NC STC), visit the NC STC website and sign up for the quarterly newsletter.

2024 State of Real-World Evidence

July 25, 2024 | 12 - 4:45 p.m. ET

Convened with the Duke-Margolis Real-World Evidence Collaborative, this public convening will provide a venue to review recent RWE Collaborative activities, strategic real-world data and real-world evidence (RWD/E) policy developments, and promising future applications of RWD/E.



This year, speakers will focus on key topics, including:

• Barriers to accessing high-quality, reliable, and relevant real-world health data sufficient for regulatory decisions
• Applications of artificial intelligence in RWE studies
• Opportunities to use RWD/E to inform payment and coverage decisions for novel technologies

Learn more and register here.



Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/Inspection: CMC for Biologics & Biosimilars

August 20, 2024 | 10 a.m. - 4:30 p.m. ET

National Press Club or Virtual

During this hybrid public meeting, experts from the U.S. Food and Drug Administration (FDA), sponsor companies, and others will explore the root causes of Complete Responses (CRs) related to quality and facility issues for original and biosimilar Biologic Licensing Applications (BLAs), regulated by the Center for Drug Evaluation and Research. CRs can result in delayed access to treatment for patients and additional time and resource demands for FDA and sponsor companies.

Learn more and register here.



Addressing Health-Related Social Needs at Scale in Medicaid: The Past, Present, and Future of North Carolina’s Healthy Opportunities Pilots

August 29, 2024 | 12 - 1 p.m. ET

Duke-Margolis and the North Carolina Institute of Medicine will host a webinar to discuss the lessons learned during the first two years of the Healthy Opportunities Pilot program’s implementation as well as its future. The discussion is meant to inform not just North Carolina audiences but also those in other states looking to address health-related social needs at scale.

Learn more and register here.



ReVAMPing the Pharmaceutical Supply Chain: Implementing Policy to Prevent Drug Shortages

The Duke-Margolis ReVAMP Drug Supply Chain Consortium hosted a meeting to explore policy solutions that reduce the frequency and severity of drug shortages and improve the reliability of U.S. drug supply chains. The meeting built on the ongoing work of the Consortium and panel discussions touched on legislative, administrative, non-governmental and private industry approaches that are underway or under consideration.

Watch the recording here.



Funding Opportunity

The Duke Clinical & Translational Science Institute invites applications for the Swann Lee Awards for Prevention of Chronic Disease using Diet and Nutrition. This program provides up to $500,000 to support translational projects, focused on diet and nutrition, that contribute to preventing diseases and promote health and wellness across the lifespan through equitable, data-driven approaches. Proposals must be innovative, transformative, with demonstrated community and stakeholder engagement and high translational potential. Please contact ctsifunding@duke.edu with any questions.



Mark McClellan spoke at an event hosted by The Hill: “Keeping Pharmacy Shelves Filled: Solutions to Address Drug Shortages,” which brought together key leaders in government and health care to discuss strategies to prevent drug shortages. Watch the recording here.

Duke University School of Medicine awarded their Early Career Mentoring Award in Clinical Research to Core Faculty member Rushina Cholera for her excellence in research mentoring for the school’s students and trainees. Congratulations, Rushina!

Will Bleser presented at a plenary panel during the Volunteers of America’s 2024 National Conference to discuss opportunities to partner with community-based organizations to address health-related social needs.

Marianne Hamilton-Lopez was a panelist at the Cell & Gene Therapy Pricing & Reimbursement Summit, discussing an evidence development model and coverage of cell and gene therapies for Medicare/Medicaid beneficiaries. Cell and gene therapies are the focus of one of Duke-Margolis’s Emerging Initiatives.



Margolis Scholars Faculty Director and Core Faculty member Kate Bundorf was a discussant, chair, and presenter at many sessions during ASHEcon, an annual convention held by the American Society of Health Economists. Kate covered a number of topics at the event, including value-based care, racial disparities, and Medicare and Medicaid models. Learn more here.