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Health systems have struggled to address the long-standing challenges to improve the affordability and quality of health care. The COVID-19 pandemic made these challenges even more clear by exposing health care’s limited ability to respond with resilience to public health crises. While clinicians went above and beyond in their efforts to care for their patients during the pandemic, the financial incentives and payment structures in place failed too often to encourage accountable, high-value care and provided limited flexibility for health care organizations to adapt to change.

At Duke-Margolis, our goal is to accelerate the successful implementation of new approaches to pay for and deliver health care—approaches that focus health care on the whole person, improve accountability for people’s health and the value of the care they received, ensure equitable access to high-quality care and build flexibility and resilience to handle future emergencies.

The Duke-Margolis Health Care Transformation effort is unique in our focus on securing pragmatic, evidence-based solutions to the most pressing, relevant health care delivery and payment policy questions. In our work, we:  

• Focus on engaging and partnering with diverse health care stakeholders, including patients, clinicians and health care delivery leaders, payers, employers, life sciences and others, to ensure we focus on the most critical issues facing health care, understand the real-world challenges to delivering better care, and encourage implementation of innovative solutions;
• Leverage the expertise of Duke faculty, researchers, and staff to generate new quantitative and qualitative evidence on pressing health policy challenges and potential solutions;
• Support the transformation of clinical practice in cardiac care, orthopedics, pediatrics, geriatric care, and other specialties by drawing on clinical experiences of those at the front lines; and
• Translate evidence into practical and feasible policy options for the Federal government, states and private sector.
   

With increased support, we can:

• Generate new, practical evidence to show how new, innovative approaches to pay for and deliver both specialty care (e.g., orthopedics, kidney care, cardiology) and primary care that will make health coverage more affordable;
• Develop new ways for health care payers and delivery organizations to meet people’s social needs and improve health equity; and
• Support North Carolina and other states as they seek to improve the value of health care by providing research, strategic and technical guidance, and engaging stakeholders.
• Identify bright spots that were able to deliver innovative care during COVID and share these models broadly to improve as we move past the pandemic and prepare better for future public health emergencies;

Recent decades have seen an influx of biomedical innovation that holds great promise for patients. The biomedical response COVID-19 pandemic demonstrated dramatically the potential—and the reality—of rapid product development, the critical value of national and international collaborations, the essential need for new and better payment and procurement options, and the fundamental need for strategies and infrastructure to ensure access to therapeutics and vaccines for the patients that need them.

Yet, while we have made enormous scientific and medical advances, more work is needed to enable an efficient, affordable, and equitable biomedical pathway. To bring about the substantive changes needed in how research is conducted, Duke-Margolis has prioritized policies and research that:

• Improve the process of medical product development and regulatory review in order to increase the treatment options available to patients,
• Engage a more diverse community of patients in clinical trials,
• Collect and share quality data,
• Enhance the health care value that these products can bring to the health care system, and;
• Enable patient’s access to promising discoveries through new payment models.

The Duke-Margolis biomedical innovation portfolio spans regulatory science, competition and drug pricing policy, payment reform, and use of real world evidence. Our work engages leaders and experts from across healthcare and the biomedical research enterprise, including patient groups, the Administration, federal agencies, private insurers, manufacturing companies and health delivery systems. 

Duke-Margolis is uniquely situated to drive change—and improve—how drugs, devices and medical products are developed, tested, regulated, distributed and monitored in the marketplace. Our core strengths are:

• Proven ability to identify challenges and find solutions by bringing stakeholders together, including researchers, innovators, and policymakers, 
• Deep understanding the life cycle of medical product development, pricing/payment, and use,
• Well-established history of working effectively with the public and private sectors on complex policy challenges, including the Food and Drug Administration and the Centers for Medicare & Medicaid Services, and with leaders and experts from across healthcare and the biomedical research enterprise, and
• Expertise and resources of Duke University, where researchers at the Duke Clinical Research Institute, the Clinical Trials Transformation Initiative, and elsewhere are driving the development of innovations that are transforming biomedical research.

With continued support, we can accomplish the following objectives:

• Bring learnings from the biomedical innovation during COVID and lead discussions to advance and accelerate the transformation of clinical trials, manufacturing, evidence generation, and payment reforms.
• Generate new, practical evidence on ways to pay for innovative technologies, medical device breakthroughs, antimicrobials, cell and gene therapies, and treatments for Alzheimer’s disease so they are accessible to the patients who need them.
• Support the Administration and states as they seek to confront the balance of innovation and affordability by providing research, strategic and technical guidance, and stakeholder engagement.

A key pillar of the Institute’s mission is to educate and train the next generation of leaders who will advance health, health equity, and the value of health care at local, state, national and global levels through equitable and evidence-based solutions. 

Reflecting this commitment, since Duke-Margolis's inception in 2016, we have developed a range of undergraduate, graduate, postgraduate education programming that heightens and hones students’ understanding of health and health care, health policy making and reform, and the capabilities that health-related organizations need to achieve greater value in care. Our programs seek to ensure that tomorrow’s leaders are equipped with the analytic, communication, and leadership skills needed in a complex health care environment. 

As a University-wide institute, an interdisciplinary lens underpins our distinctive approach to education and workforce transformation, bringing together perspectives in medicine, nursing, law, business, global health and public policy, among other disciplines. With each year, we further deepen and expand the Institute’s footprint as a health policy education leader within and outside of the Duke community.

Duke-Margolis has achieved a broad educational footprint at Duke University. Our core educational initiatives include: 

• Margolis Scholars Program
• Summer Internship Program
• Bass Connections Health Policy and Innovation Theme
• Undergraduate Health Policy Certificate Program
• Postdoctoral Scholars and Affiliated Fellows Program
• Student Collaborative on Health Policy (SCOHP)
• Health Equity Educational Initiatives
• Margolis Seminars

These programs collectively involve extensive partnerships with a number of Duke schools, including Medicine, Nursing, Fuqua (Business), Sanford (Public Policy), Law, and Trinity (Arts & Sciences). Each program is led by a Faculty Director from our Core Faculty network who is partnered with a member of our education team staff.

With more support, we would:

• Be better able to meet the burgeoning demand from Duke students for health policy education
• Design innovative curriculum and training opportunities that combine didactic and applied experiential learning opportunities that link academia, practice, and policy
• Foster more cross-campus collaborations across Duke Schools, Departments, Institutes, units, faculty, and staff to expand interdisciplinary health policy education and training at Duke
• Further Duke’s goals of diversity and inclusiveness by building a student community and workforce that prioritizes health equity, reflects diverse populations, and supports anti-racist, culturally-competent practices

Duke-Margolis is developing a major, cross-cutting initiative to address—and inform—the future of public health in the United States, building on our work during the COVID-19 pandemic. Importantly, it will also seek to infuse reforms to public health institutions and policies suggested by the pandemic with emerging 21st century medical and health system capabilities—with an emphasis on better public health outcomes and resulting improvements in trust.

Current projects seek to shape:

• the creation of population-level public health partnerships capable of identifying, tracking and responding to population health threats locally, nationally, and internationally;
• deployment of health care and treatment pathways that make comprehensive but
• efficient use of new testing and treatment modalities in a range of disease areas or health conditions; and
• processes of earning and sustaining the trust of citizens to enable collaborative approaches to the improvement of health.

Spotlight Project: Eliminating Hepatitis C in the United States 
Despite the ready availability of curative treatments for hepatitis C, the prevalence of this disease in the United States has not abated, particularly in vulnerable populations served by Medicaid. While some states have piloted approaches to a population-level plan for intervention and elimination, the financial components of such an approach have not yet been established at scale.

In partnership with the White House Office of Science and Technology Policy and clinicians at Duke Health, Duke-Margolis is convening expert stakeholders to develop a national roadmap for implementing an all-in strategy for hepatitis C elimination with Federal support—a project that will leverage progress in Test to Treat pathways established in COVID-19, lessons learned from value-based payment approaches for procuring treatments, and a 21st century vision of public health leaders as the “Chief Health Strategist” for their communities.

With more support, we can pursue similar research and policy efforts for a range of conditions and public health issues, all aimed at informing a 21st century plan for public health.

Structural racism, social and political determinants of health, and the unequal distribution of opportunities and resources routinely disenfranchise Black, Indigenous, and other people of color (BIPOC). This disenfranchisement is the root cause of disparities in health access, outcomes and patient experience in the United States and around the world. Health inequities in health policy and research often result from decisions about what research topics are pursued, who is included, and what and how data is collected, analyzed, and presented. These decisions can perpetuate or dismantle historic and current health inequities.

Duke-Margolis aims to ensure that its health policy research and leadership contribute significantly to dismantling health inequities through three main efforts: 1) applying a health equity lens to policy solutions that address systemic barriers to achieving full health and wellbeing; 2) preparing future leaders to apply health equity principles in their health policy, management or administration, clinical, or public health careers; and 3) incorporating community voices to ensure attention to community priorities, always look to build on community assets, and seek to integrate public health, health care and social infrastructure.

Importantly, Duke-Margolis continues to work with state and national leaders to identify and share best practices for the equitable distribution of COVID-19 vaccines, testing, and therapeutics, as well as preparedness for future public health emergencies. Around the world, Duke-Margolis Core Faculty members and researchers are focused on two key issues related to COVID-19 health equity: 

• Disruptions to primary care and other essential services, and 
• Distribution and access to COVID-19 vaccines and therapeutics in low- and middle-income countries.

Spotlight Project: RADx® Underserved Populations Coordinating and Data Collection Center

RADx® Underserved Populations ((RADx-UP) is a National Institutes of Health-funded consortium of more than 125 research projects studying COVID-19 testing patterns in communities across the United States and its territories. Duke Clinical Research Institute and University of North Carolina lead the RADx-UP Coordinating and Data Collection Center (CDCC). As a part of the collaboration, Duke Margolis researchers have led the project’s Policy Team and contributed to the CDCC’s Evidence Equity Academy. Duke-Margolis researchers and CDCC colleagues synthesized 23 key policy strategies necessary to close equity gaps in COVID-19 testing based on experiences from RADx-UP projects. These lessons provide a framework and important policy directions for scaling up community-based care delivery approaches. 

With more support, we can:

• expand the Duke-Margolis research portfolio to understand inequities in health care, access and outcomes, as well as the policies that institutionalize them, at the local, national, and global levels;
• build on the Institute’s ongoing efforts and research to develop evidence-based solutions to reduce inequities among historically marginalized populations;
• generate more evidence around the application of equity principles for payment models and care delivery pathways; 
• develop guidance for equity in clinical trial design and access to medical products; and
• craft curricula that embed health equity into the education of the next generation of health care leaders.

The Duke-Margolis global health portfolio focuses on accelerating and supporting health system transformation to achieve better population health—through health policy—while promoting efficiency, equity, and high-quality care. In addition to critical partnerships and collaborations across campus and around the world, this work requires the strategic design and implementation of system-level care delivery, payment, and related policy measures that enable transformative solutions to succeed. No issue has brought the importance of this vision and the Institute’s foundation of work to support it than the global response to COVID-19.

With the Duke global community and our international partners, Duke-Margolis researchers, faculty and students have implemented numerous initiatives focused on the global response to COVID-19, leading to additional analyses of high-value health system transformation, global innovation and regulatory policy, and continuous learning.

Spotlight Project: The COVID Global Accountability Platform

In 2021, Duke University and the COVID Collaborative launched the COVID Global Accountability Platform (COVID GAP), an independent initiative that provides evidence-based tracking and evolving recommendations about how governments can meet pressing needs and accelerate the end of the pandemic. A collaborative effort of Duke-Margolis, Duke’s Global Health Institute (DGHI) and Duke’s Global Health Innovations Center (GHIC), together with support from The Rockefeller Foundation and the Bill & Melinda Gates Foundation, the initiative has convened health leaders in low- and middle-income countries to hear directly from them on the effective, feasible, and sustainable strategies to strengthen the COVID-19 response worldwide.

These engagement discussions, along with the ongoing research conducted by the initiative, have resulted in numerous reports and data insights that provide the global community with impartial information regarding the state of the COVID response and identify high-priority recommendations for a more effective, efficient, and equitable pandemic response, including longer-term pandemic preparedness. Drawing on data across many sources, the Duke-Margolis and GHIC team tracks important measures of progress on commitments and remaining gaps, helping to hold leaders and organizations accountable.