Highlights
Dinner event focuses on person-generated health data

On May 2, 2017, the Duke-Margolis Center for Health Policy partnered with PatientsLikeMe and Arc Fusion to convene a unique and provocative dinner program entitled, “Person-Generated Health Data: Evidence by the People, for the People.” 

Dr. Mark McClellan introduced the evening with Sally Okun from PatientsLikeMe and also served on a panel with Anna McCollister-Slipp and Tara Montgomery that was moderated by Susan Dentzer, Duke-Margolis advisory board member and President and CEO of the Network for Excellence in Health Innovation. Dr. Gregory Daniel led a break out group where all the participants were asked to consider how person-generated health data could contribute to the central question of the evening: “What is health evidence in the networked and connected 21st century?” 

These discussions are critical to the continued progress and advancement of capturing the patient voice and experience to inform both development and regulation of drugs and medical devices. Significant challenges remain in translating this information in into reliable data and evidence, and this event is envisioned as the beginning of a series of projects focused on identifying and addressing critical next steps to leverage person-generated health data as a credible source of real-world evidence for regulatory decision-making.

New Consortium to Advance Value-Based Payment for Medical Products

Duke-Margolis has announced that it is forming a first-of-its-kind consortium to address key practical issues in advancing value-based payment arrangements for pharmaceuticals, medical devices, and innovative gene technologies. The consortium—composed of patient advocates, payers, manufacturers, and providers, as well as experts on regulatory affairs, law, and policy—will develop approaches to payment reform that support better outcomes for patients and better value across the system. Read more

News

Commentary Addresses Market Challenges to Payment Reform Evaluation

As Medicare ACOs and value-based payment arrangements proliferate in the U.S. healthcare market, so does concern about how spillover effects in health care markets may increase the difficulty of evidence-based decision making on payment reforms.

In a commentary published on the blog of the journal Health Affairs, Duke-Margolis’ Hongmai Pham, Robert Saunders, William Bleser and Mark McClellan, along with William Shrank of the UPMC Health Plan and Michael Chernew of Harvard Medical School, discuss the market dynamics that result in spillover effects. Read more

Former FDA Commissioner Robert Califf Will Head Initiatives at Duke, Verily

Robert M. Califf, MD , who in January stepped down as Commissioner of the U.S. Food and Drug Administration, has been named to new leadership roles at Duke Health, Duke University and Verily Life Sciences. Effective immediately, Califf becomes vice chancellor for Health Data Science at Duke Health and director of a newly created cross-campus center focused on integrated health data science. On June 1, he will also join the senior management team for Verily Life Sciences, an Alphabet company. His time will be evenly split between his Duke and Verily responsibilities. Read more

Contract Law Offers Solutions to Surprise Medical Bills

Surprise medical bills occur when patients inadvertently seek care from providers that are not within the patient’s insurance network, often in emergencies.  Such surprise bills tend to be very burdensome, reflecting prices that are far higher than what most insurers pay. They also subject patients to prices that are inflated, to which no insurer ever agrees, and which are set by hospitals—in fee schedules called “chargemasters”—to establish bargaining leverage against insurers. These hospital billing practices, which also ensnare the uninsured, have garnered national condemnation.

In a paper published in the American Journal of Managed Care, Duke University’s Barak D. Richman, Nick Kitzman, and Kevin Schulman, along with Arnold Milstein of Stanford University, provide a new legal analysis based on common law principles that can prohibit balance billing at inflated prices. Read more

Experts
A cancer diagnosis more than doubles an American’s chance of declaring bankruptcy, Duke medical oncologist Yousuf Zafar , MD, MHS, told an audience of nursing faculty and students at a May 10 luncheon lecture sponsored by the Duke Center for Community and Population Health Improvement. And that bankruptcy, in turn, has been shown to decrease survival rates. Read more on the Duke Research Blog .

David Anderson's analysis of Iowa's insurance market and the $12M patient is cited in Becker's Hospital Review.  Read more

Gene Tests and Long-term Care Insurance, read Donald Taylor, PhD, MPP's take in the New York Times.

Events
Expert Workshop Explores Antimicrobial Strategies

The rise in antibacterial resistant infections is a major public health threat due, in part, to the overuse and misuse of antibacterial drugs. The availability and adoption of rapid diagnostics could improve their use and help to slow the emergence of drug resistance, but there are a number of factors that hinder the market success of these diagnostics, leading to low levels of investment and development of these products.

On April 18th, Duke-Margolis convened a workshop to identify potential steps stakeholders throughout the healthcare ecosystem could take to improve the economic viability of these products and support the appropriate use of antibacterial drugs.  Workshop attendees included representatives from diagnostic companies, physicians, payers, and regulatory agencies. During the workshop, stakeholders discussed the needs of users of diagnostic tests in various clinical settings, addressed the technical and financial challenges associated with R&D for diagnostics tests, explored strategies to overcome the barriers in the regulatory process, and discussed a variety of post-market challenges to diagnostic uptake. The workshop concluded with a discussion on prioritizing actions to incentivize the development of rapid diagnostic tests.
Using Patient-Centered Clinical Outcome Assessments

The Food and Drug Administration (FDA) has taken steps over the last several years to encourage and facilitate the development and use of more patient-centered clinical outcome assessments (COAs). In support of this broader effort, the Duke Margolis Center hosted two back-to-back workshops on April 4th and 5th which focused, respectively, on deriving thresholds for measuring meaningful patient change on a COA instrument, and new approaches to 'personalizing' COAs to better reflect individual patient variation in disease manifestation and treatment response. A summary of these two workshops is currently under development and will be made available in June.

Connect with us!
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.

Our work is focused on three themes:
If you are interested in supporting health policy research at Duke University, visit our website.

This newsletter is published monthly by the Robert J. Margolis, MD, Center for Health Policy at Duke University.

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