Highlights

Duke-Margolis has formed a new collaborative to advance policy development related to the regulatory acceptability of real-world evidence (RWE). The Collaborative will engage major stakeholders to help advise and guide high priority efforts aimed at improving the development and use of RWE, with the express aim of informing and supporting the FDA as it works to meet RWE milestones as established in the 21 st Century Cures Act and the sixth Prescription Drug User Fee Act (PDUFA VI).

The RWE Collaborative consists of an advisory group that will include senior representation from medical product developers, payers, research groups, providers, patient networks, and regulators and will steer working groups and contribute to the Collaborative’s recommendations. Read More

The Robert J. Margolis, MD, Center for Health Policy, along with members of a multi-stakeholder consortium, has released a comprehensive report outlining a series of steps to address legal and regulatory barriers to value-based payment arrangements for medical products.

“Aligning payments to reflect observed or expected value in terms of patient outcomes and costs of care can improve access for patients, drive needed innovation for medical products, and avoid unnecessary costs - but many hurdles remain,” said Mark McClellan, MD, PhD, Duke-Margolis’ director.

“Many current regulations are designed for fee-for-service payment systems, to address appropriate concerns about overuse, misuse, and excess spending associated with medical products,’ added Dr. McClellan. “But they can complicate – and in some cases, prevent – adoption of value-based payments that move substantially away from fee-for-service to drive better results.”

“Current FDA rules and policy on manufacturer communications and activities related to off-label use of medical products, as well as significant concerns with the Anti-Kickback Statute and Medicaid Best Price reporting requirements are slowing progress toward substantial risk-sharing between manufacturers, payers and providers,” said Gregory Daniel, PhD, MPH, Duke-Margolis deputy director for policy. Read More
NPC and Duke-Margolis Post-Doctoral Fellowship in Health Care Policy

The National Pharmaceutical Council and the Duke-Margolis Center for Health Policy are pleased to announce that applications are now being accepted for our 2018-2020  Post-Doctoral Fellow in Health Care Policy. The fellowship will provide post-doctoral candidates with the opportunity to address the policy implications of: a) the changing health care landscape and assessing value in this new environment, b) public concerns about affordability that threaten sustained innovation, and c) the appropriate role and use of evidence. The Fellow will be expected to conduct a policy related research project and will have opportunities to interact with thought-leaders and key stakeholders in the nation’s capital and at Duke University. Applications are due January 15, 2018 Learn more and Apply Now
News

Lesley Curtis, PhD, has been named chair of the Department of Population Health Sciences, it was announced today by Mary E. Klotman, Dean, Duke University School of Medicine. Dr. Curtis has served as interim chair of the new department since July 2017, when creation of the department was approved by the Duke University Board of Trustees. From 2016-2017, Dr. Curtis served as director of the Center for Population Health Sciences , which served as a launching pad for the new department. Read More
Lessons and best practices can be adopted by commercial payers and purchasers

With a large market share, a statewide pool of enrollees, and long-term relationships with employees and retirees—state employee health plans have a unique ability to address rising costs through new payment and delivery reforms, according to a new report prepared by experts at the Duke-Margolis Center for Health Policy with funding from the Robert Wood Johnson Foundation. Plans in 18 states cover more than 10 percent of their state’s privately insured population, and all states are well-positioned to carry out new initiatives. States are implementing a variety of new payment reforms, incentivizing use of high-value insurance plans, and taking leadership roles in state-wide stakeholder health collaboratives. Read More
Trying to be an informed healthcare consumer in the United States is harder than you might think, according to researchers from the Duke-Margolis Center for Health Policy. When consumers search for healthcare prices online, only 17 percent of sites provide information on the price of common procedures, making it difficult for patients without insurance, who have high-deductible plans, or whose plans include other kinds of cost sharing to determine how much their care will cost and what they will pay out of pocket.
Experts
Does it work to dangle a carrot for patients to take healthy steps? Read more in USA Today from Charlene Wong, MD, MSPH and Robert Saunders, PhD .

Duke-Margolis Director Mark McClellan was featured in Besler's Hospital Finance Podcast on Measuring the Adoption of Alternative Payment Models.

Greg Daniel, PhD, MPH, was a panelist at the FDA/CMS Summit FasterCures Workshop, Innovations in the Science of Patient Input on December 6, 2017.

Margolis Scholar Minahil Shahid, a first-year student in the MPP program at the Sanford School, has been selected for the Quality & Innovation Scholars Program (QISP), a six-month long interdisciplinary, team-based practicum opportunity in healthcare quality improvement. The QISP scholars will complete didactic training in quality improvement, and will then be matched with a faculty mentor, and will participate in an ongoing quality improvement project. The scholarship is awarded by the Institute for Healthcare Improvement (IHI) Open School at Duke.
Events
February 5, 2018 - 9:00 am to 4:30 pm
529 14th St. NW, 13th Floor
Washington, DC 20045

This public event will bring together regulators, public health and addiction experts, and advocacy groups to discuss the FDA’s regulatory approach to medicinal nicotine in more depth, and highlight the key outstanding scientific and policy questions that will need to be addressed to support the development and appropriate use of innovative nicotine replacement therapies. Learn More and Register
February 7, 2018 - 9:00 am
1 Bethesda Metro Center
Bethesda, MD 20814

This annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the Sentinel Initiative. The Food and Drug Administration Amendments Act of 2007 authorized the Sentinel Initiative with the charge of utilizing electronic health care data for post-market risk identification and analysis of medical product safety. Learn More and Register
February 15, 2018 - 9:00 am to 4:15 pm
529 14th St. NW, 13th Floor
Washington, DC 20045

The current epidemic of opioid misuse, opioid use disorder (OUD), and opioid-related overdose remains a growing public health crisis. In support of efforts by the U.S Food and Drug Administration (FDA) to reduce the impact of opioid misuse on public health, this public workshop will examine interventions and tools being utilized by policymakers, healthcare providers, health systems, payers, and pharmacy benefit managers to ensure the safe and appropriate prescribing of opioids. These approaches may include prescribing guidelines, utilization of Prescription Drug Monitoring Programs (PDMPs), screening and risk-assessment tools, and other health system and payer strategies to manage opioid access and improve patient safety.
March 8, 2018 - 9:00 am to 4:00 pm
1777 F Street NW
Washington, DC 20006

This public workshop, convened under a cooperative agreement with the Food and Drug Administration, is being held in response to public comments received on the draft guidance “Safety Assessment for IND Safety Reporting” issued in December 2015 requesting a public meeting to discuss the draft guidance and its implications. Broadly, this workshop will provide an opportunity for the stakeholder community to continue discussions around key challenges related to IND reporting practices proposed in the guidance. Sessions will highlight industry experience implementing these approaches, and discussion topics will include but not limited to safety assessment and aggregate analysis, as well as potential best practices for unblinding of data and trial integrity, identifying expected/anticipated events, and determining reporting thresholds. Learn More and Register
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The Duke-Margolis Center for Health Policy's mission is to improve health and the value of health care by developing and implementing evidence-based policy solutions locally, nationally, and globally.
This newsletter is published monthly by the Robert J. Margolis, MD, Center for Health Policy at Duke University.

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