Real-World Impact

The Food and Drug Administration (FDA) rarely cites non-peer reviewed papers in its guidance. In the instance of its new draft guidance, however, the agency cited two Duke-Margolis papers on advancing the use of real world data and evidence. The FDA’s Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry, refers to the Center’s papers on “Characterizing RWD Quality and Relevancy for Regulatory Purposes“ and “Determining Real-World Data’s Fitness for Use and the Role of Reliability.” The Center and its Real-World Evidence Collaborative continue their important work to inform regulatory science and evidence generation. Learn more here.

HEALTH POLICY IN ACTION

Duke-Margolis, together with Duke’s Global Health Institute and its Global Health Innovation Center joined global health leaders, advocates, and organizations in a successful call for the United States to convene world leaders for a COVID summit during the United Nations General Assembly. At the US-led summit on September 22, the Biden Administration called for global leaders to recommit to ending the pandemic and aim for vaccinating 70 percent of the world’s population by mid-2022.

Center Director Mark McClellan and Core Faculty Members Krishna Udayakumar and Michael Merson championed this effort. Read about Duke’s extraordinary collaboration and leadership in Duke Today and national coverage by the Washington Post. Follow Duke’s collaborative efforts on the Center’s Global COVID-19 Response Timeline.

As the Delta variant continues to challenge the world and the flu season looms, Duke-Margolis has updated its original work on protecting the elderly and health care workers living and working in congregate care settings. Supported by The Rockefeller Foundation, the update discusses how the vaccination has lowered the risk for both vaccinated and unvaccinated residents of these settings. It also addresses how new federal funding for testing and the increased supply of over-the-counter tests has made implementing an effective testing program more straightforward as well as how testing protocols, adapted to a community’s goals and risk, and can and should be implemented to reduce community spread and protect America’s elderly and health care workers. Read the updated white paper here.

Duke-Margolis provided new guidance for schools on establishing COVID vaccination sites. The resource, “Innovative Strategies for Leveraging Schools as Vaccination Sites,” notes that with “state and local governments and K-12 educational leaders have a critical opportunity to help protect students and communities from COVID-19. School-located vaccination (SLV) can be one important tool for reopening schools safely and protecting students and their families against outbreaks of COVID-19.”

The policy brief was developed by Duke-Margolis, the COVID Collaborative, the Council of the Great City Schools, AASA: The School Superintendents Association, the National Rural Education Association, and the Rural Schools Collaborative, and includes examples of innovative approaches taken by school districts around the country to engage families and improve vaccine access in their communities. Read the policy brief here.

In a related effort, Duke-Margolis Center and the Association of Immunization Managers held a virtual symposium on September 17, which brought together public health officials, leaders in K-12 education, health care providers, and other stakeholders from across the immunization community to share best practices for improving childhood and adolescent immunization rates in school settings. Speakers discussed innovative models and lessons learned for school-located COVID-19 vaccination sites, communications strategies for engaging families and building vaccine confidence and opportunities to strengthen partnerships between public health, education, and health care providers to improve child and adolescent vaccination rates. Click here for more information and to review the meeting materials.

A new Duke-Margolis report gives state and local health officials real world, best practices to help increase COVID-19 testing and vaccination rates among hardly-reached communities. Supported by The Rockefeller Foundation, the report, “Hyperlocal Covid-19 Testing and Vaccination Strategies to Reach Communities with Low Vaccine Uptake: Considerations for States and Localities,” includes best practices from state and local health officials in Maryland, Michigan, Minnesota, New Orleans, Utah, Washington, D.C. and North Carolina. These communities are using the Biden Administration’s $6 billion in American Rescue Plan funding to support COVID-19 vaccination, testing, and treatment for populations disproportionately impacted by the virus.

A new Duke-Margolis issue brief explores the opportunity—and the federal funding—states and governors now have to improve COVID response efforts and make lasting investments in public health infrastructure. Developed in partnership with the National Governors Association and the National Academy for State Health Policy, the brief explores the critical importance of a modernized, interoperable immunization data infrastructure, capable of securely exchanging data in real time with health system and Federal partners. This brief provides governors and senior state officials with key priorities and considerations for modernizing Immunization Information Systems, including leveraging federal funding available to support these efforts. Read the issue brief, “Modernizing Immunization Information Systems: Priorities and Considerations for Governors.”

New Duke-Margolis research, published in Health Affairs, showed that from January 2018 through August 2020, an estimated 15 percent of unemployed people in North Carolina gained Medicaid coverage, with higher enrollment in more socially vulnerable counties. This low enrollment rate during a period of increased unemployment resulting from the COVID-19 pandemic indicates that the state’s Medicaid program was unable to grow fully meet greater need during periods of widespread economic hardship. This research, funded by Kate B. Reynolds Charitable Trust, builds on early evidence of the relationship between the pandemic and health insurance coverage, using North Carolina county-level unemployment and Medicaid enrollment data. The article is co-authored by Assistant Research Director Rebecca Whitaker, Core Faculty member Charlene Wong, and Duke doctoral student David Anderson. Read the full report.

RESEARCH

A new Duke-Margolis report, together with Morgan Health, details an evidence-based approach for employer-based health coverage that can deliver high quality, coordinated and affordable care for employees and their families. By focusing on advance primary care and shifting from fee-for-service to a per member per-month payment model, employers can work to overcome persistent coverage challenges of rising costs, health and health care inequities, and barriers to many employees to get the care they need to stay well. The paper, “A Pathway for Coordinated, Affordable Employer Sponsored Health Care,” is Center co-authors by Mark Japinga, Michael Zhu, Robert Saunders, and Mark McClellan.

This work was the a focus of a Duke-Margolis webinar, moderated by Politico’s Joanne Kenen, that addressed how employers can, and are, taking a more proactive role to ensure affordable, accessible, equitable care for employees, and how their leadership, together with public-sector efforts from the Center for Medicare and Medicaid Innovation (CMMI) and others, can improve health care outcomes and value. Features speakers included Elizabeth Fowler, director of CMMI; Elizabeth Carpenter, head of advisory services at Avalere; Dan Mendelson, CEO of Morgan Health, Read more about the paper in the articles published by Politico, Healthpayer Intelligence (Article 1, Article 2), and Revcycle Intelligence.

Core Faculty member Barak Richman co-authored a perspective in The New England Journal of Medicine discussing the No Surprises Act of 2020, which addresses the issue of surprise billing after medical treatment. Will this bill provide long-needed transparency in the health care sector? Read the full perspective, featured in The Duke Daily, here.

Duke-Margolis Research Director Rachele M. Hendricks-Sturrup co-authored a paper exploring the real-world evidence of patient-reported outcomes following genetic testing for specific genetic diseases, such as breast and ovarian cancer. The Center’s white paper, “A Roadmap for Developing Study Endpoints in Real-World Settings,” cites the research. Read Dr. Hendricks-Sturrup’s full paper here.

Senior Research Director Robert Saunders and Research Assistant Michael Zhu published an editorial focusing on physician group-led accountable care organizations (ACOs) and the possible causes of low participation and survival rates of those organizations. Read the editorial, “Coordination Without Consolidation? Options for ACOs.”

Health Policy Fellow Salama Freed co-authored a study, explored in a McKnight Long-Term Care News article, examining the effect of Medicaid eligibility expansion under the Affordable Care Act on the utilization of nursing home services by younger individuals and those covered by Medicaid. Click here to read “Younger Individuals Increase Their Use of Nursing Homes Following ACA Medicaid Expansion”

Core Faculty member Nina Sperber co-authored “Strategies to Integrate Genomic Medicine into Clinical Care: Evidence from the IGNITE Network,” which explores which strategies might be best suited to simplify the complexity of genomic medicine and provide guides on hot to interpret data. Read the full article here.

Vermont Business Magazine covered a recent Duke-Margolis case study that examines the University of Vermont Medical Center’s Comprehensive Pain Program and the innovative program implemented by Blue Cross Blue Shield of Vermont to improve treatment options for patients who depend upon opioids for musculoskeletal pain. 

Duke-Margolis and FDA will hold for a two-day, virtual public workshop that will convene regulators, clinical researchers, providers, patient advocates, and other stakeholders to exchange information and input on prescriber education’s potential role in alleviating the evolving opioid and substance abuse crisis. As a recent Policy & Medicine article states, “the dynamics of the opioid and substance abuse crisis have shifted significantly since the Opioid Analgesic REMS was initially implemented and new opportunities may have emerged for improving prescriber education.” In this public workshop participants will discuss the current landscape of the crisis, the state of opioid prescriber education, recent trends in opioid prescribing and pain management, the current state of opioid prescriber education requirements and opportunities to improve them, the potential role of prescriber education in alleviating the crisis, considerations for the future role of mandatory prescriber education through a REMS, and next steps for opioid prescriber education.

Click here for additional information and to register.

The Sentinel Initiative was launched in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is comprised of several components including the Sentinel System, the Active Risk Identification and Analysis System, the Biologics Effectiveness and Safety Initiative, and FDA Catalyst. The FDA is committed to facilitating stakeholder engagement on approaches to modernize the Sentinel Initiative’s capabilities.

The annual public workshop is a gathering of the Sentinel community and leading experts to share recent developments within the Sentinel Initiative, provide training on the Sentinel System’s tools and data infrastructure, and promote engagement and collaboration with patients, industry, academia, and consumers. The 13th Annual Sentinel Initiative Public Workshop will convene on November 8-9, 2021, and is hosted by Duke-Margolis under a cooperative agreement with FDA. The workshop will be held as a virtual webinar and provide an opportunity for attendees to discuss recent achievements and developments as well as engage with the broader community of patients, consumers, and scientific stakeholders.

This year’s meeting will feature a keynote by Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), as well as presentations from numerous expert panelists who will provide updates on key Sentinel Initiative developments, milestones, and strategic aims. The discussion will also consider recent activities and applications of the Sentinel Initiative as part of the U.S. FDA’s efforts to protect and promote public health during the COVID-19 pandemic.

Click here for additional information and to register.

Duke-Margolis, collaborating with FDA, hosted a two-day virtual public workshop entitled “Pharmacodynamic Biomarkers for Biosimilar Development and Approval” on September 20-21, 2021. This virtual public workshop provided a forum for regulators, biopharmaceutical developers and academic researchers to discuss the current and future role of pharmacodynamic (PD) biomarkers in improving the efficiency of biosimilar product development and approval. Click here for more information and to review the meeting materials.

Core Faculty member Lesley Curtis addressed the decrease in life expectancy in the U.S. in 2020 in a series of articles by NPR and BBC News. "It is impossible to look at these findings and not see a reflection of the systemic racism in the US,” she noted. “The range of factors that play into this include income inequality, the social safety net, as well as racial inequality and access to health care.”

Margolis Scholar Ethan Borre Ethan will present his abstract, Development and validation of DeciBHAL-US: A novel microsimulation model of hearing loss across the lifespan, at the Society for Medical Decision Making’s 43rd Annual North American Meeting on Tuesday October 19^th at 4:00pm. Click here for more information and to register for the meeting.

Senior Policy Fellows Aparna Higgins and Susan Dentzer, along with Center Director Mark McClellan, presented at this month’s Virtual Collocated Value-Based Payment Summits. Aparna participated as both a panelist and moderator while Susan, a co-chair of the event, served as moderator and interviewer in her sessions. Dr. McClellan delivered the keynote at the close of the event.

Aparna Higgins also contributed at The MedTech Conference 2021: MedTech Amplified presenting in a session called “Ensuring Continued Access to Breakthrough Devices through Evidence Generation.” Visit the session page for more information.

Duke-Margolis Center for Health Policy is pleased to announce two new Core Faculty members, Anna Hung and Michael Merson. Anna is a pharmacist and health services researcher interested in payer and patient decision making related to pharmacy benefits. Michael is the Wolfgang Joklik Professor of Global Health and the Director of the SingHealth Duke-National University of Singapore (NUS) Global Health Institute. A long-time leader at Duke, Mike is the founding director of DGHI, a former Vice Chancellor for Duke-NUS Affairs, and Duke’s former Vice President and Vice Provost for Global Affairs. Outside of Duke, he was Director of the WHO Global Program on AIDS, and has authored more than 180 articles, focus primarily in the area of disease prevention. Welcome to Duke-Margolis Anna and Mike!

Do you want to be part of health policy in action? Do you want to work on the leading health policy issues confronting cities, states, the nation, and the globe? The Duke-Margolis team is a dynamic, high impact national leader in leveraging policy to ensure high quality, affordable care for all. Multiple positions are currently available—please click here to view all of our career opportunities.