2017

Annual Report From the Director

Dear Friends and Colleagues,

I’m pleased to present the 2017 Annual Report of the value-based payment and pricing, global accountable care Duke-Margolis Center for Health Policy. In 2017, we and real-world data and evidence. celebrated our formal public launch in Washington, DC, This Fall, we welcomed our initial group of Margolis and expanded our contributions to the field of health policy Scholars, including two distinguished graduate students and management, working closely with thought leaders from the Sanford School of Public Policy and three and a wide range of stakeholders at the state, national from Duke Law, as we continue to expand our graduate and global level. Our support in this effort grew, as we education footprint. These students have participated in hosted our distinguished advisory board on the Duke orientation activities, are attending our bi-weekly seminar University campus, recruited strong academic leadership, and are active participants in the university-wide health welcomed faculty from across Duke and from outside the policy community that we are building at Duke. We are in institution to our ranks, and grew our research support and the process of expanding the program and recruiting the collaborations to advance our work. 2018–2019 cohort. As a result, the Duke-Margolis Center is already having I want to thank everyone who has helped make 2017 a substantial impact on such issues as value-based care such a great year for our Center. We are grateful to the and payment reform for health services, drugs, treatments, Robert J. and Lisa Margolis Family Foundation and to Bob and devices; state-level health reform; more efficient and Lisa for their ongoing personal involvement. We hope health care coverage; and investment in preventive care this annual report will inform and inspire you to support and infrastructure for improving population health. We are and participate in our work. also expanding our interdisciplinary educational programs, focusing on the new combinations of competencies Sincerely, and expertise needed by the next generation of health care leaders. While the breadth and impact of our work is difficult to capture in any report, we invite you to read about some of our key 2017 accomplishments in our key mission areas of healthcare transformation, biomedical innovation, Mark B. McClellan, MD, PhD education and global health policy. These contributions Director and Robert J. Margolis, MD, Professor of Business, span cost-effectiveness analysis, state-level reform, and Health Policy From the Founder

Dear Friends and Colleagues,

Thanks to the excellent faculty and staff in North Carolina work that reflects the quality of the education I received and Washington, DC, our research collaborators, partners in medical school. The work of the Duke-Margolis Center and funders, our exceptional advisory board, and the for health policy is inspired by this education and a career support of ’s leadership, the Duke- devoted to improving equitable access to high quality, Margolis Center for Health Policy has adapted quickly to efficient and effective patient centered care to all. Duke a fast-moving policy environment and made significant is committed to leadership and innovation, to teaching contributions to discussions about health care’s most and learning, and to an ethos of discovery, service, and an challenging issues. The Center is both an academic ultimate commitment to healing that inspires individuals research center and a policy laboratory where stakeholders and organizations across the and around can come together to analyze, propose and evaluate ways the world. to improve health in the United States and beyond. Thank you for your interest in our work—we hope you In 2017 the Center celebrated its launch and held will be inspired to join us. public events where stakeholders from across the health care system and biomedical sciences came together to Sincerely, tackle tough, complex and technically challenging issues. Center members and partners also came together to plan and carry out research and education programs that ask tough questions, propose innovative ways to find answers, and help the next generation of health policy leaders chart their course. Robert J. Margolis, MD Duke-Margolis is fostering an intellectual community Founder and Chair, Duke-Margolis Advisory Board at Duke University and beyond that, I believe, is doing

1 Celebrating Milestones

Thanking our Founder

A reception honoring Bob and Lisa Margolis followed the public launch event. After remarks from Center director Dr. Mark McClellan and Dr. Margolis, attendees watched a video interview with former Public Launch Duke University President Richard Brodhead and Dr. Margolis, which uke-Margolis’ public launch was held February 9, president of the National Academy of Medicine, David focuses on Dr. Margolis’ love 2017 at the Knight Conference Center at the Brailer, managing partner, Health Evolution, David Feinberg, for Duke and his motivation in Newseum in Washington, DC, featuring the president & CEO, Geisinger Health, Michael O. Leavitt, founding the center (viewable at D expertise of our affiliated faculty and members Leavitt Partners and former governor of , and Debra L. healthpolicy.duke.edu/founder). of the Duke-Margolis advisory board in panel discussions Ness, president, National Partnership for Women & Families. “The incredible generosity of focusing on the fast-changing health policy environment A panel on high-value biomedical innovation was Bob and Lisa Margolis through the for healthcare transformation and high-value biomedical chaired by Peter Orszag, vice chairman of investment Margolis Family Foundation have innovation. U.S. Sen. Richard Burr (R-NC) offered banking & global co-head of healthcare, Lazard, and made the Center possible and opening remarks. included Joseph Jimenez, former CEO of Novartis, David accelerated our progress in the More than 250 people attended the event, which King, chairman and chief executive officer, Laboratory first two years,” said Dr. McClellan. reached an additional 15,000 individuals through our Corporation of America, Jessica Mega, chief medical officer, “But what’s really exceptional is various social media outlets and the webcast. Verily, and Dan Mendelson, president, Avalere Health. Dr. Margolis’ personal involvement Following a welcome from Dr. Bob Margolis, Susan The event concluded with an overview of the Center’s and advocacy, which he offers to Dentzer, president and CEO, Network for Excellence in educational initiatives and a brief video of students enrolled our faculty and staff day after day Health Innovation (NEHI), moderated a panel focused on in the Bass Connections course on NC Reform. and week after week, with both healthcare transformation, which included Victor Dzau, generosity and thoughtfulness.”

2 2017 Selected Highlights

Leadership Mark McClellan, MD, PhD, and Elizabeth A. McGlynn published Duke-Margolis launched a multi-stakeholder Value Based an overview of methods and considerations in an article, Payment collaborative intended to advance value-based Gillian Sanders Schmidler, PhD, joined Duke-Margolis as Deputy “Strategies For Assessing Delivery System Innovations,” payment approaches for high-cost drugs, gene therapies, and Director, Academics, where she guides and helps develop our published in Health Affairs. devices that have high potential for delivering better value. The academic research activities, oversees research proposal collaborative released a white paper addressing key legal and development, helps recruit, retain and develop high-potential Dr. McClellan, William Schrank from the University of Pittsburgh regulatory challenges to value-based payment approaches. research faculty, and oversees and supports the expanding Medical Center, and Duke-Margolis’ Robert Saunders, PhD, education programs for the Center. published a JAMA Viewpoint arguing that evaluations designed The Center launched a collaborative to advance policy to align with stakeholder needs – whether academic rigor, development related to the regulatory acceptability of real- Amanda McBroom Brooks, PhD, joined the Center as speed, timely feedback, flexibility, or scalability – could world evidence (RWE). A workshop to discuss the use of real- Director of Operations. help broaden implementation of payment reforms while also world data (RWD) and RWE in drug development and regulatory supporting better policy making. decision-making drew more than 1000 online and in-person Healthcare Transformation attendees. In advance of this workshop, the Center published Dr. Taylor and colleagues published a study concluding that a white paper that outlines considerations stakeholders should In January, Duke-Margolis released findings of its work with reimbursement for advanced care planning discussions can make when exploring the potential for regulatory use. the Commonwealth Fund, “Translating International Models of improve quality of life. Accountable Care for High-Need, High-Cost Populations in the A Duke-Margolis Team presented a set of recommendations Dr. McClellan co-chaired, “Vital Directions in Health and Health United States” aimed at advancing the use of data from mHealth apps and Care,” an initiative of the National Academy of Medicine calling wearables for real-world evidence generation. The Second Panel on Cost-Effectiveness in Health and Medicine, on more than 150 leading experts to assemble evidence-based a national effort co-chaired by strategies for advancing health and health care.

Gillian Sanders Schmidler, PhD, published a perspective on their In December, the Center hosted a public meeting, “FDA’s New Education & Workforce Development upcoming book and the role of cost-effectiveness analysis in Regulatory Framework for Tobacco and Nicotine: the Role of Duke-Margolis’ Bass Connections NC Medicaid Reform student evaluating trade-offs between health care costs and outcomes. Medicinal Nicotine”. team presented their results to policy advisors and the Duke-Margolis, DGHI, The Center for Policy Impact in public in Raleigh. Global Health, and Policy Cures released a major report, Biomedical Innovation The first class of Margolis Scholars from the Sanford School of “Strengthening the United States Government’s Role in Product & Evidence Development Public Policy’s Master of Public Policy program and Duke Law Development for Global Health.” A team led by deputy director Gregory Daniel, PhD, MPH, was recruited and began the program in the Fall semester 2017. A team led by Donald H. Taylor, PhD, received a grant from the developed a proposal for a new payment model (PAVE) Robert Wood Johnson Foundation to provide timely guidance intended to spur investment in high priority antibiotics in a to states on new payment models and health programs by way that reflects their public health value and the need for providing timely evidence on their overall impact, guidance on sustainable use. how policies can be tailored for a state’s unique context, and solutions to implementation challenges.

3 Advanced Medical Homes in Medicaid

Healthcare With support from the A.J. Fletcher Foundation, an informal group of health policy experts led by Aaron McKethan, PhD, developed specific policy Transformation recommendations for the Secretary of the NC Department of Health and Human Services for implementing an “Advanced Medical Home” payment and delivery model for NC Medicaid. Recommendations included a practical framework for next-generation patient-centered care management, a spectrum of associated payment models, and development of data and technical assistance to support providers’ transition to a value-based health system. These recommendations were incorporated into an official waiver strategy that was submitted to the Centers for and Medicaid Services. The analysis and proposed framework are now being shared with Helping States other states. Implement Reform Analyzing Multi-Payer Episode Payment Models he Margolis Center has been at work on a range of state health policy projects in North Carolina Under the Center for Medicare and Medicaid and beyond to support a transition to value-based Innovation’s State Innovation Models three states— T care at the state level. Arkansas, Ohio and Tennessee—have received support to design and implement care payment models with participation from both Medicaid and commercial payers. These models may reward or penalize providers based on their average care costs and quality measures for condition-specific episodes of care. These initiatives demonstrate a potentially promising strategy for implementing multi-payer payment reforms leading with Medicaid. Mark McClellan, MD, PhD, and Aaron McKethan, PhD, at Duke-Margolis are collaborating with colleagues at the Vanderbilt University School of Medicine to identify practical insights from these efforts to help other states evaluate payment reform strategies based on multi-payer episodes of care.

4 Multi-State Health Policy Reform Improving Patient and A multidisciplinary effort to identify and communicate Consumer Engagement important policy-relevant discoveries using NC Medicaid and other data, led by Aaron McKethan, PhD, is a joint Peter Ubel, MD, has conducted and the quality of patient decisions effort with the Duke Department of Population Health significant research into how about breast reconstruction led by Lesley Curtis, PhD, and Duke’s new Health Data patients receive information after mastectomy. Science center (Duke Forge) led by , MD, and in healthcare situations, which Charlene Wong, MD, MSPH has will build on activities undertaken by the Patient-Centered can help clinicians in discussing forged several collaborations in Outcomes Research Network (PCORnet), coordinated at treatment options and cost this area, working with Dr. Ubel Duke under the leadership of Adrian Hernandez, MD, and with their patients. This has to examine how people make Dr. Curtis. The collaboration includes colleagues with deep resulted in publications looking at insurance purchasing decisions on clinical, informatics, analytics and policy expertise, bringing discussions of cost in oncology, the exchanges, especially in terms together small, focused teams of subject matter experts to and a further study by Yousef of comprehension of their choices define high-priority policy problems/needs, develop written Zafar, MD, and colleagues that and how the overall architecture use Medicaid waivers to backstop analytic plans, perform code-level data analysis, identify was a top article mentioned in of the insurance exchange site the insurance exchanges, which results, implement changes, and track results. This initiative the media in 2017. Other studies affected their eventual decision. was published in September 2017 is a collaboration with the NC Department of Health & examine challenges communicating Also looking at the structure of in the Health Affairs blog. This Human Services, which will provide access to large claims genetic information, how and when the exchanges, David Anderson, timely research can inform the and other datasets for the state. The project already has patients choose palliative care, MS, offered a novel proposal to debate about the future of the interest and participation from other states. The first joint and where project focuses on profiling prescribing patterns related to there are opportunities to improve prescription opioids, with other projects in process. it going forward. Clinical Gastroenterology and Hepatology. The team is also Dr. Wong and colleagues working closely with Duke faculty members in orthopedics, also published a JAMA Internal Understanding Reforms anesthesia and critical care, and radiology on payment Medicine research letter: “Finding reform in those specialties. These collaborations include healthcare prices online—How that Work to Transform clinical care redesign to succeed under payment reform as difficult is it to be an informed well as principles for new payment models. healthcare consumer?” The Health Care Duke-Margolis also disseminated key findings related to study received significant media payment reform in the United States via the Health Affairs attention. She is also leading a The Center has been working closely with leaders in blog, including four publications on the current state and new project evaluating evidence different specialties to identify opportunities for payment gaps of evidence on payment reform, how spillover effects on the effectiveness of health reforms to support health care delivery transformation in present analytic challenges for assessing single payment behavior incentive programs major areas of clinical care. Faculty member Ziad Gellad, reform initiatives, how employers could be involved in in Medicaid, which will inform MD, from Gastroenterology, Mark McClellan, MD, PhD, encouraging more evidence about payment reforms, how states and Medicaid managed Mark Japinga, MPaff, and Rob Saunders, PhD, authored a to reduce barriers to efficient evaluations, and the growth care organizations who are perspective on the evolving payment reform landscape for of Accountable Care Organizations and alternative payment considering implementing such gastroenterology in the September 2017 issue of the journal models in 2017. incentive programs.

5 and delivery innovations that implement Care Reforms” (Krishna Udayakumar, Health Policy accountable care. MD, MBA, Andrea Thoumi, MSc, MPP, This work is guided by a 16-member Jonathan Gonzalez-Smith, MPaff, and advisory board, led by GHIC director Kushal Kadakia). in a Global Krishna Udayakumar, MD, MBA, which In addition, Mark McClellan is leading has already provided valuable input. a Health Foundation-sponsored study to Based on this work, two papers were identify key policy gaps in accountable accepted into Health Affairs’ November care implementation in England. In June Context issue on Global Health: “Accountable Care 2017, the team co-hosted a 100-person Reforms Improve Women’s and Children’s event with Imperial College Health Health in Nepal” (Mark McCelellan, Partners and a 20-person roundtable uke-Margolis benefits from partnerships across MD, PhD, Krishna Udayakumar, MD, with the Health Foundation to pressure Duke University, including the Duke Global Health MPA, Andrea Thoumi, MSc, MPP, and test a set of recommendations on the Institute, the Center for Policy Impact in Global Jonathan Gonzalez-Smith, MPaff) and policy improvement opportunities that D Health, the Duke Global Health Innovation Center “Improving Care and Lower Costs through policymakers in England could consider (GHIC) and its partner organization, Innovations in Health Accountable Care: Evidence and Lessons to assist organizations implementing Care. These collaborations span the Center’s health care from a Global Analysis of Accountable accountable care reforms. transformation, biomedical innovation and educational portfolios – a few highlights are presented here.

Learning from International Experiences with Accountable Care GHIC Launches with Duke-Margolis Support In May 2017, the Commonwealth Fund awarded Duke- Margolis and Innovations in Health Care a Phase I The Global Health Innovation Center was launched in for Health Financing Solutions.” The project grant to begin a study of integrated delivery and policy 2017 to study and support the scaling and adaptation objective is to advance universal health care innovations in a global context that might be used to of health innovations, and related policy reforms, in selected sub-Saharan African countries. Theses transform care for high-need, high-cost populations in to address critical health challenges worldwide. The collaborators are also a USAID-funded project the U.S. The project’s aim is to accelerate the uptake of GHIC is a joint initiative of the Duke Global Health entitled “Regional Action through Data” (RAD). In successful policy, payment, and delivery innovations from Institute, Duke-Margolis and the Duke Institute for the first year of the project, the research team abroad that can improve the care of high-need, high-cost Health Innovation. conducted a landscape analysis of six countries and populations in the US. This was followed by a Phase II GHIC has hit the ground running, collaborating two regional organizations to evaluate the policy award to support scouting and curation of innovations for with Duke-Margolis on a subcontract to a 5-year environment for barriers and opportunities for the these populations, focusing on aligned policy, financing, USAID-funded project entitled “African Collaborative RAD consortium to develop health innovations.

6 Policy Impact

uke-Margolis communicates with the policy community through in-person briefings and private meetings, convening activity through D both public and private events, media outreach, a monthly email newsletter, social media and co- sponsorship of invitation-only events addressing pressing policy topics. In 2017, the Center hosted or co-hosted 10 public and 13 private events, reaching more than 2,250 policymakers, influencers, experts, advocates and other stakeholders. All Duke-Margolis public events are webcast, reaching an additional viewership of more than the New York Times, JAMA Viewpoints, NEJM Catalyst, 2,675 individuals. Video archives of events have been and STAT First Opinion. Duke-Margolis experts have viewed more than 12,000 times. The Center live-tweets been quoted in the media more than 70 times in 2017, all public events, resulting in a Twitter following that more with many studies receiving extensive media coverage than doubled over the course of 2017. including a top-ranked JAMA Oncology study on financial Center members published more than 220 peer- toxicity in cancer care. These appeared in high-impact reviewed publications in 2017 and presented at high- publications such as the New York Times, Washington profile conferences such as AcademyHealth, DRIVE-AB, Post, USA Today, the Boston Globe, STAT News, Axios, and National Academies public meetings. Politico, and numerous industry publications. The Center has begun conducting online media Policy analysis and proposals created by Duke- briefings with health policy reporters in advance of Margolis have been incorporated by policymakers into major research announcements including Value-based key proposals, such as North Carolina’s Medicaid waiver Incentives for Antimicrobial Development, a RWE application and discussions at the federal level regarding framework and findings on the use of apps and wearables accountable care, value-based payment reform, end-of- FDA Commissioner Scott in research. These sessions have garnered interest from life care, and regulatory policy. Our work has influenced Gottlieb opens a Duke-Margolis Politico, the Wall Street Journal, Inside Health Policy, value-based pricing strategies by industry leaders in public event focused on the STAT, and multiple industry-focused publications. the introduction of first-in-class therapeutics, and by FDA’s new regulatory framework Over the course of 2017, Duke-Margolis experts patient advocacy organizations focused on decreasing the for tobacco and nicotine. have published op ed columns in top-tier outlets such as financial burden for oncology patients.

7 Biomedical Innovation & Improving the Science of Development & Review

Duke-Margolis convenes expert workshops and Evidence Development public conferences aimed at informing approaches to reviewing and regulating medical products. These convening activities generally fall within four general categories: Real World Evidence world data (RWD) sources, promising opportunities to improve the credibility of observational study Supporting the Development & Use of New ver the last decade, regulatory decision- designs, and lessons learned from actual industry Drug Development Tools making has utilized real-world evidence experience with RWD- and RWE-enabled regulatory The Center has convened expert workshops focused on (RWE) mainly in the area of post-market submissions. Performance Outcome Assessments and Clinical Outcomes safety. The U.S. Congress has tasked Dr. Daniel observed, “We have the technical O Assessments, including personalized CAOs. Other focused work FDA with addressing the challenge of using data and methodological tools to incorporate real-world includes the analytical validation of assays used to qualify generated from patients’ clinical experiences as evidence into regulatory decision making, but more biomarkers and surrogate endpoints in Cancer clinical trials. part of the 21st Century Cures Act. In addition, the progress is needed on when and how to apply RWE U.S. Food and Drug Administration and its industry within the regulatory framework. Ultimately, we Standardizing & Improving Post-Market Safety Regulation partners agreed to explore opportunities to apply hope that better clarity in how such high-quality In 2017, Duke-Margolis built on its experience working to RWE to regulatory decision making as part of the evidence can inform FDA’s decisions will further improve post-market safety for medical devices to explore sixth Prescription Drug User Fee Act commitments bolster support for a more efficient evidence risk evaluation and mitigation strategies (REMS) for drugs submitted to Congress in January 2017. development infrastructure that makes it easier and devices and to provide feedback on safety assessment Duke-Margolis is helping lead the way in for RWE to guide a range of decisions to improve for investigational new drug reporting. Work in this area RWE challenge areas related to data, methods, the value and quality of care.” (Learn more at also focused on performance indicators for drug quality and policy. Under a cooperative agreement with healthpolicy.duke.edu/RWE). and packaging, storage, and disposal solutions to enhance FDA, led by Gregory Daniel, PhD, MPH, Adrian In addition, under cooperative agreement opioid safety. Hernandez, MD, MHS, and Morgan Romine, MPA, with FDA’s Center for Devices and Radiological Exploring Innovative Statistical Methods & Trial Designs the Center released a major white paper and held a Health, the Center convened a working group with New statistical methods and trial designs can help bring large public conference on regulatory acceptability expertise across the mobile health (mHealth) and products to market faster and with better safety data. of RWE in September 2017. healthcare ecosystems to identify the challenges The Center convened workshops in 2017 focused on drug Outside of this agreement, the Center in advancing the use of real-world, high frequency, development for oncology and rare diseases. launched a RWE Collaborative that engages and/or longitudinal data from mHealth apps major stakeholders including medical product and wearables for secondary research. This Enhancing Regulatory Review Processes for Medical Products developers, payers, research groups, providers, work resulted in an action plan that outlines the Duke-Margolis has partnered with FDA to better understand patient networks, and regulators to help advise challenges and potential solutions to make data the public health impact of safety labeling changes, advance and guide efforts to improve development and derived from consumer and clinical-use mobile apps structured benefit-risk assessments, and understanding use of RWE. Initial projects will explore primary and wearables usable for evidence generation on how international harmonization of expedited programs can considerations for assessing the quality of real- medical products. increase patient access to innovative therapies.

8 Value-Based Payment for Drugs & Devices

Policy Solutions Supporting Innovation & Stewardship for Antimicrobial Drugs Members of the Duke- Antimicrobial resistance is a serious public health threat Margolis Value-Based that is growing due, in part, to inappropriate use of Payment Consortium antibiotics and a lack of new antibiotic development. Market advisory group discuss challenges and a poor return on investment have lead legal and regulatory many companies to discontinue development efforts and barriers at the Center’s incentives are needed to encourage development of these Washington, DC Office. critical drugs and the rapid diagnostics needed to provide the right drug to the right patient at the right time. Duke-Margolis engaged stakeholders to develop and refine a proposal, released in August, that would provide developers with a return of investment while supporting stewardship. The Priority Antimicrobial Value and Entry (PAVE) Award would provide high priority antimicrobial The Duke-Margolis Value-Based Payment Consortium developers quick access to funds upon market entry through a transition to population-based payments that In April 2017, Duke-Margolis Center formed map for its work including workshops for emphasize the value of the drug rather than the volume a new Consortium led by Gregory Daniel, each working group, held in late 2017. The used. The proposal was highlighted in an editorial, authored PhD, MPH, and Marianne Hamilton-Lopez, team issued a landscape analysis and a by Mark McClellan, MD, PhD, and Gregory Daniel, PhD, MPH PhD, to address key practical issues in paper, written in collaboration with external in the Journal of the American Medical Association. advancing value-based payment models for legal experts, identifying key legal and drugs, medical devices, and transformative regulatory obstacles for advancing value- therapeutics including genetic technologies. based payment and explore feasible policy Distribution of revenue with PAVE** The Consortium includes an Advisory options for addressing these barriers. Group that includes senior executives from Future work will focus on financing manufacturer, payer, provider, and patient innovations for transformative therapies, advocacy organizations to identify potential data and evidence infrastructure, and an gaps, provide guidance, and propose overall framework for value-based payment strategies – including three product-specific arrangements. workgroups to address challenges specific Separately, the Center has also to pharmaceuticals, gene technology, and convened workshops to address drug medical devices. pricing, value of care, and the unique Through a series of workshops and clinical challenges of Alzheimer’s Disease papers, the Consortium has laid out a road and cancer therapies.

Market entry reward Fee-for-service Value-based contracts

** Numbers are based on previous antimicrobial sales and are for illustrative purposes only. 9 Education & Workforce Development

core part of Duke-Margolis’ Bass Connections legislators, chairs and staff for the relevant committees, mission is to educate the and other stakeholders. The team presented their final next generation of health Members of Duke-Margolis have been actively involved recommendations in Raleigh in April. Barak Richman, JD, A policy leaders. The center in Duke’s Bass Connections Program, a university-wide PhD, and Donald H. Taylor, PhD, provided faculty leadership has found substantial interest across initiative to allow both graduate and undergraduate and Hilary Campbell provided staff leadership to five Duke University in new educational students with to experience exposure to “inquiry across graduate and ten undergraduates who took the course. approaches to address this the disciplines, partnership with unlikely fellow thinkers, challenge. In addition to internship sustained mentorship in teams and the chance to Global Alliance on Disability and Health opportunities for undergraduate experience the intersections of the academy and the Innovations Team and graduate students, the broader world.” In 2017, our faculty and staff have provided Center partners with the Fuqua leadership on two teams. Duke-Margolis faculty including Janet Prvu Bettger, PhD, School of Business Health Sector Brandi Granger, PhD, Dr. Taylor, and Gavin Yamey, MD, MPH, Management program to provide Medicaid Reform Advisory Team helped lead this course, which conducted a mixed-methods, executive and continuing education. multinational study to examine organizational, governance, In addition, faculty participate in Team members investigated the political and legal financing and policies associated with integrated, person- ongoing education for national and procedures involved in Medicaid reform as well as potential centered health care, and particularly for people with international health leaders on health coverage models and business opportunities to a new disability from injury, illness or surgery. Both effective reforms in health care and meet the needs of North Carolina’s Medicaid beneficiaries. undergraduate and graduate students representing more biomedicine. The team partnered with representatives from advocacy than twelve disciplines from across Duke participated in organizations and community health providers, as well as the course.

10 Margolis Scholars in Health Policy & Management Summer The Margolis Scholars Program combines academic and • Assistance to attend conferences or meetings to Internships experiential training in health policy and management support knowledge and idea exchange, professional for exceptional graduate and professional students from networking, and presentation skill development; Duke-Margolis had the privilege of across Duke. The program provides an interdisciplinary • Additional one-on-one mentorship from health policy working with seven highly-accomplished perspective on key health policy and management issues and management faculty; and, student interns during the summer of as well as relevant practical and research opportunities • Training to hone professional skills, such as 2017. Interns included undergraduate to support academic and professional development. presentation, interviewing, and negotiation. and graduate students from Duke While Margolis Scholars will encompass a range of University and other institutions, graduate disciplines in Health Policy and Management, The Center is currently working with other graduate representing DukeEngage, bioethics the inaugural cohort includes students from the Sanford and professional programs across Duke to expand the and science policy, global health, public School of Public Policy and Duke Law. Duke-Margolis Scholars program in the coming years. policy, pre-med, and economics worked successfully recruited two Scholars for the 2017–2018 on topics including drug regulatory academic year in collaboration with Sanford’s Master of policy, Medicaid reform, the opioids Public Policy (MPP) program and three in collaboration crisis, global accountable care, hospice with Duke Law. The inaugural class of scholars were 2017–2018 and end of life, health care exchanges, welcomed at a lunch in September, where they had the Margolis technology applications for health and opportunity to meet faculty and staff from both the Scholars financial toxicity in cancer care. Durham and Washington, DC offices to explore their needs and program goals. Scholars receive support in: Margolis Seminar • Development of deep knowledge and skill in health policy and management through enrollment in The Margolis Seminar is held twice selected courses; Kelly Hamachi Jami King monthly to connect the Duke-wide health • Internship and job placement; LAW LAW policy community, and to help people • Opportunities to make hands-on contributions form, develop, and shape their health to health policy and management research and policy-related work. Most seminars cover consulting projects, as well as the development and research or policy analysis in progress, organization of conferences and workshops; while others include presentations by • Membership in the Margolis Seminar series, including faculty, staff, and visitors on significant the opportunity to present research in progress; newly-released research, legislative or • Networking opportunities with leaders across the regulatory developments. In 2017, the health policy and management sector, including field Seminar met fifteen times and involved trips to Washington, DC and Raleigh, NC; more than 120 students, faculty and • Access to thought leaders in senior-level policy Minahil Shahid Meredith Stewart Madhu Vulimiri staff as attendees or presenters, linking PUBLIC POLICY LAW PUBLIC POLICY and management positions at global, national, and the Durham and Washington, DC offices local levels; through videoconferencing.

11 Advisory Board Members

he Duke-Margolis advisory board is made up of exceptional leaders from all sectors of T health care including payers, 2017 Members providers, researchers, policymakers and patient advocacy organizations. The Robert J. Margolis, MD Susan DeVore Dan Mendelson, MPP group met in Washington, DC in February Chair President and Chief Executive President, Avalere Health and in Durham, NC in November 2017. Officer, Premier, Inc. In addition, individual members have Drew Altman, PhD Debra L. Ness, MS generously given their time and advice on President and Chief Executive Officer, David Feinberg, MD, MBA President, National Partnership Duke-Margolis project where they offer Henry J. Kaiser Family Foundation President & Chief Executive for Women & Families particular expertise. Officer, Geisinger Health David Brailer, MD, PhD Peter Orszag, PhD The Duke-Margolis Center is overseen Managing Partner, Health Evolution Joseph Jimenez Vice Chairman of Investment Banking & by Provost Sally Kornbluth and Chancellor Former Chief Executive Officer, Novartis Global Co-Head of Healthcare, Lazard of Health Affairs Gene Washington, Tony Coles, MD, MPH (M’86) who also serve on the Center’s External Founding Investor, Chairman and Chief Jessica Mega, MD, MPH Joseph R. Swedish, MHA (G ’79) Advisory Board, chaired by Robert J. Executive Officer, Yumanity Therapeutics Chief Medical Officer, Verily Executive Chairman, Anthem Healthcare Margolis, MD. Director Mark McClellan, (formerly Google Life Sciences) Patrick Conway, MD, MSc Barbara Wachsman MD, PhD, and deputy directors Gregory President and CEO of Blue Cross and David P. King, JD Daniel, PhD, MPH and Gillian Sanders Blue Shield of North Carolina Chairman and Chief Executive Officer, Schmidler, PhD, also attend meetings in Laboratory Corporation of America their leadership capacity. Susan Dentzer President and CEO, Network for Governor Michael O. Leavitt Excellence in Health Innovation (NEHI) Leavitt Partners

12 New Leadership New Faculty In August, Duke-Margolis appointed Gillian Sanders Schmidler, PhD, Professor of Population Health Sciences, as Deputy Director Monica Lemmon, MD, is assistant professor in for Academics. She guides the Center’s academic research activities, the division of pediatric neurology and directs Duke’s oversees proposal development, helps recruit, retain and develop Neuro-Intensive Care Nursery Program. Dr. Lemmon high-potential research faculty, and oversees the expanding education studies clinical and patient centered decision-making, programs for the Center including mentorship of junior faculty, and clinician-family communication. Her research aims graduate, and post-graduate fellows. Her work complements Greg to characterize the parent experience of caring for Daniel, PhD, MPH in his role as Deputy Director, Policy, leading external infants with neurologic disease, challenges in parent- Gillian Sanders Schmidler, PhD engagement. Her distinguished record of scholarly achievement clinician communication, and parent decision making DEPUTY DIRECTOR, ACADEMICS has focused on transparent and rigorous methods for synthesizing around withdrawal of life-sustaining treatment, Dr. evidence on the comparative effectiveness of treatments, practices, and policies; and she has extensive Lemmon develops and tests communication intervention applied research experience on strategies to inform and improve decision making and health policy. She strategies for parents of critically ill infants. has sustained a broad grant, serving as Principal Investigator on 38 research projects funded through both public and private sources. Her work has resulted in more than 140 publications in major peer- Aaron McKethan, PhD, is assistant professor in reviewed journals. the department of population health in the School of Medicine and a Duke-Margolis Senior Policy fellow, overseeing efforts on state-level health reform. Corinna Sorenson, PhD was appointed Faculty Director of the He leads a research, policy analysis, and policy Margolis Scholars Program and is an assistant professor of population development portfolio that examines the impact of health in the School of Medicine. In her role at Duke-Margolis, she state programs and policies on cost, quality, and provides academic oversight and day to day leadership of the Margolis population health, that disseminates the evidence Scholars program and collaborates with Dr. Sanders Schmidler to lead and best practices, and that provides guidance the Center’s educational portfolio including curriculum development for state health policy reforms to improve health and other efforts aimed at advancing health policy and management outcomes and lower costs. Corinna Sorenson, PhD education at Duke. Dr. Sorenson’s scholarly work centers on assessing FACULTY DIRECTOR OF THE MARGOLIS value, including patient-centered definitions of value. SCHOLARS PROGRAM Charlene Wong, MD, MSPH, is an assistant professor of pediatrics with a dual role as a primary care physician for people ages 12-26 and as a Amanda McBroom was appointed Director of Operations in June policy researcher. She focuses on addressing young 2017. She is the Program Manager of the Evidence Synthesis Group/ people’s reproductive health concerns, chronic Evidence-based Practice Center at the Duke Clinical Research Institute illnesses, behavioral challenges, and developmental (DCRI). She received her undergraduate degree in Biochemistry and difficulties. Her research focuses on improving the Molecular Biology from Oklahoma State University and her doctorate consumer experience with accessing health and health in Biochemistry from the Duke University Medical Center as a James care, exploring innovative strategies that leverage B. Duke Graduate Fellow. Her role within Duke-Margolis spans financial behavioral economics and technology to improve and business operations, resource management, program and project Amanda J. McBroom, PhD youth well-being, and studying the impact of health management oversight, and strategic development. DIRECTOR OF OPERATIONS policy on young people.

13 Leadership Faculty Adrian Hernandez, MD, MHS* Vice Dean for Clinical Research, School of Medicine; Gary G. Bennett, PhD Professor of Medicine, Cardiology; Associate Professor in the Department of Psychology and Director, Duke Clinical Research Institute Mark B. McClellan, MD, PhD* Neuroscience; Bishop-MacDermott Family Professor of Director and Robert J. Margolis, M.D., Psychology and Neuroscience; Faculty Co-Director of the Erich Huang, MD, PhD Professor of Business, Medicine and Policy Center for Biobehavioral Health Disparities Research; Assistant Professor in Biostatistics and Bioinformatics; Research Professor of Global Health; Associate Professor Assistant Professor of Surgery; Co-director, Duke Forge in Medicine; Associate of the Duke Initiative for Science Nandan Lad, MD, PhD & Society; Member of the Duke Cancer Institute Assistant Professor of Neurosurgery; Janet Prvu Bettger, ScD, FAHA Member, Institute for Brain Sciences Gregory W. Daniel, PhD, MPH, RPh* Associate Professor; Director, Health Policy and Implementation Monica Lemmon, MD Deputy Director, Policy and Clinical Science, Department of Orthopaedic Surgery Professor, Fuqua School of Business Assistant Professor of Pediatrics Don W. Bradley, MD, MHS-CL Richard C Mather III, MD, MBA (Chad) Consulting Associate Professor, Community and Assistant Professor; Vice Chairman of Practice Innovation & Family Medicine; Executive Director, The Practical Director Joint Health Program, Department of Orthopaedic Playbook (www.PracticalPlaybook.org) Surgery, Duke Health; Faculty, Duke Clinical Research Institute; Gillian Sanders Schmidler, PhD* George Cheely, Jr., MD President, North Carolina Orthopaedic Association Deputy Director, Academics and Professor of Medical & Program Director, Care Redesign Program; Aaron McKethan, PhD Population Health Sciences, School of Medicine Assistant Professor of Medicine, Hospitalist Physician Chief Data Officer, NC Department of Health and Human Jeff Clough, MD, MBA Services; Assistant Professor of Population Health Assistant Professor of Medicine, General Internal Medicine Sciences, Duke University School of Medicine; Senior Policy Fellow, Duke-Margolis Center for Health Policy Lesley Curtis, PhD* Chair, Department of Population Health Sciences; Thomas Owens, MD Ellen de Graffenreid, MA, MBA Professor of Medicine, General Internal Medicine; Chief Medical Officer, Duke University Health System; Director of Communications Director, Center for Pragmatic Health Services Associate Professor of Medicine and Pediatrics Research in the Duke Clinical Research Institute Steven Patierno, PhD Ziad F. Gellad, MD MPH AGAF Professor of Medicine, Community & Family Associate Professor of Medicine; Associate Vice Chair for Clinical Medicine, Pharmacology and Cancer Biology; Innovation; Director of Quality, Division of Gastroenterology Member, Duke Cancer Institute

Amanda J. McBroom, PhD Bradi Granger, PhD Eric Peterson, MD, MPH, FA Director of Operations Associate Professor of Nursing; Associate Director of Fred Cobb Distinguished Professor of Medicine in the Duke Translational Nursing Institute; Director of the Division of Cardiology; DukeMed Scholar; Executive Duke Heart Center Nursing Research Program Director of the Duke Clinical Research Institute (DCRI)

14 Arti K. Rai, JD Donald H. Taylor, PhD, MPP* Visiting Fellows Elvin R. Latty Professor of Law; Founding Director, Professor in the Sanford School of Public Policy; Assistant Professor Center for Innovation Policy at Duke Law; Duke of Community and Family Medicine; Associate Professor in the Visiting Fellows participate in working groups and Innovation and Entrepreneurship Research Fellow School of Nursing; Affiliate, Duke Global Health Institute; Affiliate activities that support research on a number of of the Duke Initiative for Science & Society; Member of the Duke initiatives in health care delivery and payment Shelby D. Reed, PhD Clinical Research Institute; Member of the Duke Cancer Institute reform, biomedical innovation for pharmaceuticals Professor, Departments of Population Health Sciences and and devices, and health policy education and Medicine; Director, Preferences Evaluation Research Group Peter Ubel, MD* workforce development. The appointment as a Madge and Dennis T. McLawhorn University Professor, Professor of Jerome P. Reiter, PhD Visiting Fellow is reserved for individuals who, Business Administration, Fuqua School of Business; Professor in Professor in the Department of Statistical Science through their collaboration with the Duke-Margolis the Sanford School of Public Policy, Sanford School of Public Policy; Center, are deserving of an affiliation but do not have Barak Richman, JD, PhD Professor of Medicine, General Internal Medicine; Member of Duke any formal academic responsibilities nor do they Edgar P. and Elizabeth C. Bartlett Professor of Cancer Institute; Affiliate of the Duke Initiative for Science & Society receive financial support from the university. Law; Professor of Business Administration Krishna Udayakumar, MD, MBA* David Ridley, PhD Associate Professor of the Practice of Global Health, Regina LaBelle, JD Dr. and Mrs. Frank A. Riddick Associate Professor of the Practice Duke Global Health Institute; Associate Professor—Track Principal, LaBelle Strategies of Business and Economics; Faculty Director of the Health IV in Medicine, General Internal Medicine Mohit Kaushal, MD, MBA Sector Management program, Fuqua School of Business Charlene Wong, MD, MSPH Special Advisor at General Atlantic Devdutta Sangvai, MD, MBA Assistant Professor of Pediatrics David Muhlestein, PhD, JD Associate Professor in Community and Family Gavin Yamey, MD, MPH Chief Research Officer, Leavitt Partners Medicine; Associate Professor in Pediatrics; Associate Professor of the Practice of Global Health, Duke Professor in Psychiatry and Behavioral Sciences Edmund Pezalla, MD, MPH Global Health Institute; Professor of the Practice Vice President and National Medical Director for Frank Sloan, PhD in the Sanford School of Public Policy Pharmaceutical Policy and Strategy at Aetna J. Alexander McMahon Professor of Health Policy and Yousuf Zafar, MD Management; Professor of Economics Trinity College of Arts & Michael Pignone, MD, MPH Associate Professor of Medicine, Medical Oncology Sciences; Professor of Business Administration, Fuqua School Chair of Internal Medicine at the University Assistant Professor in the Sanford School of Public Policy; of Business; Professor in the School of Nursing; Professor of of Dell Medical School Member of the Duke Cancer Institute; Affiliate, Duke Global Public Policy Studies, Sanford School of Public Policy Health Institute; Member in the Duke Clinical Research Institute Corinna Sorenson, PhD Assistant Professor of Medicine; Adjunct Professor in * Member of the 2017 Duke-Margolis Faculty Executive Committee the Sanford School of Public Policy; Member in the Duke Clinical Research Institute; Faculty Director of the Margolis Scholars in Health Policy and Management Initiative

15 Research Staff J. Kelly Davis Lauren Schauer Partners & Funders Research Associate Research Assistant Duke-Margolis faculty and staff work on a number of grants Research Directors Katherine Frank Monika Schneider, PhD and projects in partnership with or funded by organizations Senior Research Assistant Research Associate Marianne Hamilton Lopez, inside and outside of Duke University. In addition to Duke PhD, MPA Meredith Freed, MPP Isha Sharma faculty members’ primary colleges and schools, we are Research Director, Value-Based Senior Research Assistant Senior Research Assistant grateful for the support of: Payment Reform Jonathan Gonzalez-Smith, Christina Silcox, PhD Aetna Foundation A.J. Fletcher Matthew Harker, MBA, MPH MPaFF Research Associate Foundation Project Director – Evaluation Hub Research Associate American College of Andrea Thoumi, MSc, MPP Cardiology Foundation Global Health Robert Saunders, PhD Katie Greene, MPP Managing Associate Technologies Coalition Research Director, Payment Research Associate BECR Center (USDA) and Delivery Reform Greenwall Foundation Alexander Gunn, MBS Laura and John Research Associate Operations Staff Arnold Foundation The Health Foundation Research Fellows Hannah Huffstetler Center for Health Lilly USA, LLC Hannah Campbell Hilary Campbell, PharmD, JD Research Associate Policy & Inequalities Staff Assistant Medical Device Research Fellow Research at Duke Mark Japinga, MPA Epidemiology Network Tiffany Cervi University Ilona Friedman, PhD Senior Research Assistant Grants and Contracts Administrator Merck Sharp & Research Fellow Center for Medicaid & Madeline Katz Dohme Corporation Angelique Kosempa Medicare Innovation Research Assistant, BECR Center Executive Assistant to Dr. Mark McClellan MITRE Corporation Research Staff The Commonwealth Christine Kirby, MA Susan Lasley Fund Gordon and Betty David Anderson, MS Research Associate Office of Research Support Moore Foundation Research Associate Duke Cancer Institute Farrah Mandanay, MA Catherine Liao, MSPH National Adam Aten, MPH, MSc Research Associate Duke Clinical Duke Health Government Relations Pharmaceutical Council Research Associate Research Institute Andrew Olson, MPP Toni Nicholson PhRMA Foundation Mary Barks Project Leader, Health Policy Evidence Duke Global Health Staff Assistant ​Research Associate Hub; Duke Clinical Research Institute Institute Robert Wood Johnson Sarah Supsiri, CGMP Foundation Will Bleser, PhD, MSPH Jingyuan “Juan” Qian, MPP Duke Population Events Manager Research Associate Senior Research Assistant Research Institute United States Food and Suky Warner Drug Administration Jonathan Bryan Elizabeth Richardson, MSc Duke University Executive Assistant to Dr. Mark McClellan Research Assistant Managing Associate Bass Connections World Innovation Elizabeth Murphy Summit for Health Jessica Burnell Morgan Romine, MPA Executive Assistant to Dr. Gregory Daniel Research Assistant Managing Associate

16 The following individuals and organizations are members of Duke-Margolis Consortium for The following individuals and organizations are members of the Developing a Path to Value-Based Payments for Medical Products: Duke-Margolis Consortium Real-world Evidence Collaborative:

Alan Balch Michael Goettler Dana Gelb Safran ADVISORY GROUP Sally Okun Chief Executive Officer, Patient Global President, Rare Disease Chief Performance Measurement Vice President of Policy & Amy Abernethy Advocate Foundation Group, Pfizer Innovative and Improvement Officer/Senior Vice Ethics, PatientsLikeMe Senior Vice President, Health, Pfizer Inc. President, Enterprise Analytics, Blue Thomas Barker Oncology, Flatiron Health Eleanor Perfetto Cross Blue Shield of Massachusetts Partner and Co-Chair, Healthcare Darin Gordon Senior Vice President, Strategic Marc Berger Practice, Foley Hoag President and CEO, Gordon Craig Samitt Initiatives, National Health Council Co-Chair, Joint ISPOR/ISPE & Associates, LLC Executive Vice President and Amy Bassano Special Task Force on RWE in Richard Platt Chief Clinical Officer, Anthem Deputy Director, Center for Medicare Tim Hunt Healthcare Decision-Making Executive Director, Harvard and Medicaid Innovation, Centers Senior Vice President, Corporate Lewis Sandy Pilgrim Health Care Institute; Barbara Bierer for Medicare and Medicaid Services Affairs, Editas Medicine Executive Vice President, Clinical Chair, Department of Population Faculty Director, Multi-Regional Advancement, UnitedHealth Group Medicine, Harvard Medical School Jonathan Blum Leigh Anne Leas Clinical Trials Center of Brigham and Executive Vice President, Vice President and US Country Michael Sherman Women’s Hospital and Harvard Amy Rudolph Medical Affairs, CareFirst Head, Health Policy, Novartis Chief Medical Officer and Vice President and Head of HE&OR Paul Bleicher BlueCross BlueShield Senior Vice President, Harvard and Digital Medicine, Novartis Nick Leschly Chief Executive Officer, OptumLabs Pilgrim Health Care Pharmaceuticals Corporation Marc Boutin Chief Executive Officer, bluebird bio Riad Dirani Chief Executive Officer, Surya Singh Joanne Waldstreicher Jeff Marrazzo Vice President, Global Health National Health Council Corporate Vice President and Chief Medical Officer, Co-Founder and Chief Executive Economics and Outcomes Research, Chief Medical Officer, Specialty Johnson & Johnson Perry Bridger Officer, Spark Therapeutics Teva Pharmaceuticals Client Solutions, CVSHealth Vice President, Global Value, Richard Willke Steve Miller Nancy Dreyer Payer Access and Public Policy, Susan Winckler Chief Science Officer, International Senior Vice President & Chief Global Chief of Scientific Affairs, Edwards Lifesciences Chief Risk Management Officer, Society for Pharmacoeconomics Medical Officer, Express Scripts IQVIA Real-World Insights Leavitt Partners/President, and Outcomes Research Alexandra Clyde Joshua Ofman Leavitt Partners Consulting Carlos Garner Corporate Vice President of Global Marcus Wilson Senior Vice President, Global Vice President, Global Regulatory Health Policy, Reimbursement and Linda Wiant Co-Founder and President, Healthcore Value, Access & Policy, Amgen Affairs, Eli Lilly and Company Health Economics, Medtronic Chief, Medical Assistance Plan Parashar Patel Division, Georgia Department John Graham OBSERVERS Gavin Corcoran Vice President, Global Health of Community Health Vice President and Head, Value Evidence Senior Vice President and Chief Jacqueline Corrigan-Curay Policy, Boston Scientific and Outcomes, GlaxoSmithKline Medical Officer, Allergan Director, Office of Medical Policy, CDER, Jonathan Perlin Jacqueline Law U.S. Food and Drug Administration Patrick Courneya President of Clinical Services and Vice President, Global Head Real Executive Vice President and Amanda Wagner-Gee Chief Medical Officer, Hospital World Data Science, Genentech, Chief Medical Officer, Hospitals, Program Officer, National Academies of Corporation of America A member of the Roche Group Quality and Care Delivery Sciences, Engineering, and Medicine Excellence, Kaiser Permanente Contact Us Connect with us CREATIVE BY H·A ThirtyOne | hathirtyone.com The Robert J. Margolis, MD, healthpolicy.duke.edu EDITORIAL BY Center for Health Policy FACEBOOK » DukeMargolis Ellen de Graffenreid, MA, MBA | Director of Communications, Duke University Duke-Robert J. Margolis, MD, Center for Health Policy TWITTER » @DukeMargolis Washington, DC PHOTOGRAPHY BY 1201 Pennsylvania Avenue, 5th Floor Brian Strickland | brianstrickland.zenfolio.com Washington, DC 20004 Stay up to date with email 202-621-2800 notification of Center news and events Durham, NC (Mailing Address) 100 Fuqua Drive, Box 90120 healthpolicy.duke.edu/newsletter Durham, NC 27708 919-660-7963