HEALTH POLICY IN ACTION

Congress is considering two measures that would modernize tools the FDA uses to oversee the regulation of diagnostic tests and cosmetics. In a new op-ed, Center Director Mark McClellan and fellow former Food and Drug Administration (FDA) Commissioner Scott Gottlieb contend that the FDA is currently working from an outdated regulatory playbook that has left gaps in its oversight of safety and effectiveness and makes it more difficult to introduce new innovations. The new legislation would strengthen protections for consumers and patients for both diagnostic tests and cosmetics, and make it easier for manufacturers to introduce better products. Read the full opinion, published in Stat here and a follow-up article from National Journal here.

Mark McClellan and Assistant Research Director Nitzan Arad contend that the Inflation Reduction Act (IRA), signed by President Biden on August 16, 2022, is the “most substantial drug payment and coverage legislation enacted since the Medicare Modernization Act of 2003.” The authors discuss, in a two-part Health Affairs Forefront article, the potential consequences of the IRA related to rebates, alternative payment arrangements, drug development, and evidence to guide drug use, and call for important clarifications before the law is implemented. Read “Drug Pricing Reform in the Inflation Reduction Act: What Are The Implications?” Part 1 and Part 2 to learn more about important consequences that flow from the IRA’s Medicare coverage and drug pricing provisions, and issues related to them needing resolution to ensure affordability without an undesirable impact on drug innovation and access.

A strategic pillar for the Center of Medicare & Medicaid Services (CMS), improving multipayer alignment across key features of value-based payment models is widely recognized as critical for reducing administrative burden and achieving common goals, such as improving population health and affordability. Duke-Margolis researchers Mark Japinga, Yolande Pokam Tchuisseu, Robert Saunders, and Mark McClellan co-authored “A Path Forward for Multipayer Alignment to Achieve Comprehensive, Equitable, and Affordable Care,” which details a pragmatic, iterative multipayer alignment framework to achieve increasingly substantial alignment through three main components:

Click here to read the full paper.

Duke-Margolis Policy Analyst Kamaria Kaalund lead a team of authors, including Duke-Margolis researchers Andrea Thoumi and Rushina Cholera, in publishing “Assessment of Population-Level Disadvantage Indices to Inform Equitable Health Policy” in The Milbank Quarterly. The paper recognizes that the rapid uptake of disadvantage indices during the pandemic highlights investment in implementing tools that address health equity to inform policy. The authors compare disadvantage indices and discuss the considerations surrounding which indices are suitable for specific communities, objectives, potential interventions, and outcomes of interest. Read the full article here.

Duke-Margolis Visiting Fellow David Muhlestein, Senior Research Director Robert Saunders, Assistant Research Director William Bleser, and Mark McClellan discuss how, after years of Accountable Care Organization (ACO) growth, the latest ACO tracking updates show plateaus or even slight declines in their Health Affairs Forefront article “Growth of Value-Based Care and Accountable Care Organizations In 2022.” Click here to read the rest of the article where they argue that although growth in pure ACO models has slowed, more activity is taking place within other value-based models.

Policy Research Associate Nicholas Harrison and former Duke-Margolis Senior Policy Analyst Valerie Parker co-authored the summary of a September 2021 FDA and US Health and Human Services-funded Duke-Margolis Workshop, “Pharmacodynamic Biomarkers for Biosimilar Development and Approval,” in American Society for Clinical Pharmacology and Therapeutics. To promote efficient biosimilar development and regulatory review, the FDA has been investigating strategies to advance the use of pharmacodynamic (PD) biomarkers in PD similarity studies and this mini-review summarizes the presentations and panel discussions from the 2021 workshop.

Duke-Margolis Research Director for Real World Evidence (RWE) Rachele Hendricks-Sturrup co-authored a publication in Clinical Pharmacology & Therapeutics entitled “The Aetion Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation Initiative: Oncology,” which describes a framework for systematically emulating trials in oncology and comparing RWE findings to their randomized clinical trial (RCT) counterparts. Duke-Margolis is a member of the Aetion CARE Initiative, which brings together health care leaders to facilitate multiple trial emulations using various data sources to understand where real-world evidence is appropriate and where it is not. Click here to read the full paper and here to learn more about the Aetion CARE Initiative.

The COVID Global Accountability Platform (COVID GAP) published the 16^th edition in their ongoing series of Accountability Reports, which highlight and analyze recent developments; track progress toward national, regional, and global targets; and identify high-priority recommendations for a more effective, efficient, and equitable pandemic response and preparedness. The current issue highlights the newest antiviral to hit the market, which just received emergency use authorization in Japan.

Last month COVID GAP co-hosted a Plenary Session with The Bill & Melinda Gates Foundation, Africa CDC, and Amref Health Africa at the 2nd International Conference on Public Health in Africa. Duke-Margolis Core Faculty Member Krishna Udayakumar moderated the session discussing “The COVID-19 pandemic – Lessons Learned for Future Health Threats, Prevention, Preparedness and Response.” Click here to learn more.

In a recent article from Voice of America News, reporting on the sunsetting of the COVAX program in 2024, Krishna Udayakumar commented on the impact of this decision by the Global Alliance for Vaccines and Immunization (GAVI), noting “there will be major questions coming from the transition, including how many low- and middle-income countries will continue to receive the financing and logistics support they need, to the impact on GAVI’s other immunization programs of integrating COVID-19 vaccination.” Read the full article here.

Over the last two years, Duke-Margolis has provided critical, timely support to the North Carolina Department of Health and Human Services for planning, capacity-building, and implementation of their innovative Healthy Opportunities Pilots (HOP) program to address social needs through Medicaid. This work is supported by the Robert Wood Johnson Foundation and the Kate B. Reynold Charitable Trust. The effort, led by Assistant Research Director Will Bleser, disseminated findings to policymaker, provider, and community audiences through policy briefs, national webinars, community-facing infographics, and feedback sessions with the state. An article, appearing in the North Carolina magazine The Assembly, features Will in its coverage of the HOP program. Click here to read the full article.

Duke-Margolis held a virtual meeting supported by the Kate B. Reynolds Charitable Trust to solicit feedback on the design of regional stakeholder convenings in 2023 to support North Carolina’s Healthy Opportunities Pilots. The meeting was attended by Healthy Opportunities Pilots leaders at all administration levels, from NC Department of Health and Human Services (NC DHHS) and prepaid health plans, to network leads, human service organizations, and others. The discussion touched on 1) ensuring equitable access to services, 2) success and innovations to share with regional stakeholders, 3) opportunities to align resources and infrastructure, 4) common and unique challenges to addressing social needs and health equity through the Pilots, 5) opportunities for cross-sector communication, and 6) health policy initiatives and organization focused on addressing social needs beyond the Pilots.

The NC Health Care Transformation Workgroup, convened by Duke-Margolis, met to discuss the potential focus areas for a joint state-federal initiative called the State Transformation Collaborative, including concrete steps to strengthen primary care and reduce provider burden in the state. Liz Kasper, Acting Deputy Director for Population Health at NC Medicaid, provided opening remarks where she reiterated NC DHHS’s commitment to achieving whole-person coordinated care and highlighted NC DHHS’s efforts in addressing operational changes needed to further improve Medicaid Managed Care, some of which are highlighted in its recently published Medicaid Delivery Reform and Value-Based Payment Update

Diagnostic tests help clinicians diagnose and manage patients with threatening drug-resistant infections, guiding appropriate antibiotic prescribing and improving patient care. However, adequate coverage and reimbursement is necessary to empower clinicians to provide the right test, for the right patient, at the right time. With support from Wellcome Trust, Duke-Margolis hosted a private roundtable in June 2022 to research barriers that limit bacterial diagnostics’ coverage, reimbursement, and utilization, and to consider policy approaches to advance the role of bacterial diagnostics in patient care, among efforts to combat drug-resistant infections and antimicrobial resistance (AMR). A new Duke-Margolis report, including the key takeaways from this roundtable was recently released, click here to learn more.

Artificial Intelligence (AI), including machine learning (ML), is becoming more integrated in all phases of drug development— from drug discovery and clinical research to post-marketing surveillance. An expert workshop, held by FDA and Duke-Margolis, focused on AI/ML innovations in different phases of drug development, with an emphasis on those areas that have the greatest need for regulatory clarity. Visit the event webpage for additional information.

Duke-Margolis hosted a virtual roundtable, supported by the Commonwealth Fund and Arnold Ventures, to discuss federal and state policy opportunities for advancing safety net participation in value-based payment models.

Duke-Margolis hosted a convening, supported by Arnold Ventures, to discuss policy opportunities to operationalize specialty care engagement in population-based payment models. Attendees discussed pathways towards comprehensive specialty payment reform, challenges that have hindered specialty care involvement in population-based payment models to date, and promising policy and organizational strategies to enable broader specialty care participation.

In a related effort, Assistant Research Director Frank McStay participated as a panel member during a CMS Listening Session for Specialty Care. During the listening session, aimed at introducing CMS’s recently released specialty care strategy, McStay spoke about what types of incentives could support specialists engaging with primary care providers to deliver accountable care. Noting the Center’s recently published work on specialty care payment reform, McStay reviewed opportunities to incentivize collaboration between primary care and specialty care physicians, including data and interprofessional consultation payments.

Research Director Christina Silcox was quoted in a recent edition of Politico Nightly regarding the continued efficacy of the at-home rapid antigen COVID-19 tests. Read the full piece here.

Sarah Dunn Phillips associate director of education at Duke-Margolis, completed a year-long professional development program through the Duke Management Academy. She and classmates were celebrated at a recent graduation ceremony. The academy is designed to nurture the leadership skills of the staff members who will help shape Duke’s future. Congratulations Sarah!

Core Faculty Member Mina Silberberg authored “Research Translation: A Pathway for Health Inequity,” published in Clinical and Translational Science, where she posits that research translation naturally furthers health inequity. Click here to read the full piece and what mitigation steps Mina suggests can be taken.

Sara Debab is a new Policy Research Assistant on the Center’s Health Care Transformation team. Sara is a recent graduate from Virginia Commonwealth University (VCU) with a degree in interdisciplinary science. She has a diversity of experiences across health policy and health equity, including working on community-based health equity research projects at VCU School of Medicine, and contributing to state and federal policy initiatives to expand value-based care and promote primary care physician independence at Aledade, Inc. Her research interests are centered on advancing value-based health care policies to effectively address sociopolitical determinants of health and improve health equity.

Hilary Campbell rejoins Duke-Margolis Center as a Center Policy Fellow for Institutional Research, Analytics, and Program Development where her input spans the Center’s research and educational aims. On the research side, Hilary contributes to a range of timely projects, including her focus on launching the Center’s 21st century public and population health initiative. Hilary also plays a key role in strategic efforts to expand the Center’s quantitative research capabilities by growing and maintaining the Center’s analytic and data resource capacity. Additionally, she works collaboratively with our Education and Operations teams to develop strategies and manage the systematic collection, evaluation, and dissemination of metrics and data relevant to Duke-Margolis analytic and educational programs.

Hilary received her JD from Duke School of Law, her PharmD from UCSF, and brings a unique interdisciplinary perspective to her health policy work. Most recently Hilary served as Director of the North Carolina Health Professions Data System at UNC’s Sheps Center for Health Services Research.

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 with new ones added frequently. Click here to view all of our career opportunities.