Addressing the Opioid Epidemic in North Carolina
On May 16, more than 70 government officials, clinicians, and research experts participated in a meeting to develop a research agenda to combat the opioid epidemic in NC. The meeting was a collaborative effort by Duke-Margolis, UNC, and NC DHHS.
At the meeting, Governor Roy Cooper and Secretary Mandy Cohen (pictured above) shared their priorities and vision for implementing efforts in this area.
Aaron McKethan
(pictured above) presented a quantitative analysis of opioid trends in the North Carolina Medicaid population, and data experts from state governments in Tennessee and Kentucky offered suggestions and lessons learned.
The participants collaborated in working groups to create the ultimate output of the meeting: a prioritized list of the most important policy-relevant questions that can be answered with data in the near term in order to make impact on the opioid epidemic.
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Duke-Margolis on the Health Affairs Blog
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A Preferable Path For Thwarting Pharmaceutical Product Hopping
Auto-Enrollment Is A Good Idea, Here’s How To Make It Even Better
Recently, the team of Stan Dorn, James Capretta, and Lanhee Chen—in an
excellent pair
of posts on Health Affairs Blog—sketched out a pathway toward using an auto-enrollment process that would promote much higher levels of insurance coverage, while being minimally coercive and invasive. One of their major policy goals was to improve the aggregated morbidity of the Affordable Care Act (ACA) individual market risk pools to bring down nonsubsidized premiums and lower per capita federal subsidies for subsidized individuals. Auto-enrolling uninsured individuals, who tend to be healthier than insured individuals, into the individual market where “metal” plans are sold would achieve this goal. Read more from
David Anderson on the
Health Affairs Blog.
Implications Of CMS Mandating A Broad Load Of CSR Costs
In October 2017, the Trump administration
eliminated federal funding to reimburse insurers for cost-sharing reduction (CSR) subsidies, which they are obligated to provide to qualifying enrollees in the Affordable Care Act (ACA) Marketplace. President Donald Trump had threatened to eliminate CSR funding throughout 2017, so insurers and insurance regulators in many states had anticipated the move by adding the cost of CSRs to premiums for 2018.
In the days following the elimination of CSR funding,
48 of 51 states (all but North Dakota, Vermont, plus the District of Columbia) allowed insurers to add CSR costs to 2018 premiums in some manner. To compensate insurers for the cost of CSRs, five states used a “broad load” uniform surcharge that applied to all individual policies on and off the exchanges. All other states used some variant of a “silver load,” in which the cost of CSRs was added only to silver-plan premiums.
A spreadsheet with each state’s approach is available here
. All of this was done in a hodge-podge fashion in 2017, with insurers and state regulators unsure what would happen at the federal level, and the official termination of CSR funding coming less than three weeks before the start of open enrollment. Read more from
David Anderson and colleagues on the
Health Affairs Blog.
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Medicare Advantage Leads Transition from Fee-for-Service to Alternative Payment Models
Information Gap Remains on Alternative Payment Model effectiveness
A new report
finds that while Medicare Advantage health insurance plans are driving the widespread adoption of ‘alternative payment models’ designed to improve care while reducing costs, the limited amount of publicly available information means little is known about which reforms are working well and why.
The report offers policy solutions to help overcome regulatory barriers and create a more favorable payment reform environment, including multi-payer evaluations and value-based insurance design. This work is funded through a grant from the
Robert Wood Johnson Foundation.
Read the full report
.
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FDA Examines Eligibility Criteria in Clinical Trial Design and Product Development
"Efforts to devise more informed and productive clinical research programs, while also addressing demands for expanded access to experimental therapies, has focused attention on the role of inclusion/exclusion criteria in clinical research. Sponsors design clinical trials to demonstrate efficacy of a drug on a target population, usually including sufficient subgroups to support broader product use. More innovative and adaptive trial designs may facilitate including certain rare disease populations and demographic minorities that also may benefit from treatment, but with an eye to avoiding requirements that could add to the cost and challenges in conducting necessary studies.
FDA is exploring these issues, as discussed at a recent public workshop on
Evaluating Inclusion and Exclusion Criteria in Clinical Trials in Washington, D.C., organized by the Duke-Margolis Center for Health Policy in collaboration with FDA. While these issues have been reviewed frequently in the past, recent legislation authorizes further assessment of FDA eligibility policies and of National Institutes of Health (NIH) research standards. Read more in
Applied Clinical Trials.
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A simple change of direction can make restaurant calorie labels more effective
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Gregory Daniel, PhD, MPH
and Marc Berger, arguing for the affirmative, defeated a team made up of Nancy Berger and Marni Hall at
ISPOR 2018
- "Debating the Future of Healthcare".
The statement debated was that "FDA should be able to approve a new indication for a drug based on real-world evidence from observational studies alone." Their argument that compelling and consistent evidence from multiple well-designed observational studies in different populations, with transparency about data curation, data transformations, and analytic approaches, should not be ignored by FDA simply because studies were not randomiz
ed. While this may not be possible in all cases and would only be sufficient when the RWD are appropriate and of high quality, the debate concluded that FDA should be able to approve new indications where methods and clinical contexts permit valid and reliable evidence from observational studies.
Charlene Wong, MD, MSPH,
gave an invited talk at
Duke Clinical Research Day: “Health Engagement: Activating people with personal data and incentives.”
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In addition to Gregory Daniels' debate victory, Duke-Margolis was well-represented at
ISPOR 2018.
Shelby Reed, PhD,
is the organization's current president.
Reed Johnson, PhD,
from Duke's Department of Population Health received the Avedis Donabedian Lifetime Achievement Award.
Adrian Hernandez, MD, MHS,
spoke on a plenary panel about real-world evidence. Reed,
Gillian Sanders-Schmidler, PhD,
and
Corinna Sorenson, PhD
, presented updates on PhRMA Foundation projects and Lauren Schauer (pictured left) presented a poster on work she did with Sorenson and
Mark McClellan, MD, PhD.
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Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics
June 14, 2018 -
8:30 am to 5:00 pm
Location and Registration available soon!
Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will focus on the range of non-traditional pharmaceutical approaches being developed to combat bacterial infections. Speakers will address the importance of development in this area, the full spectrum of technologies currently under development, and the outstanding scientific challenges in assessing efficacy of these products in pre-clinical and clinical settings. Discussion will help to prioritize challenge areas in which additional considerations and research will need to be developed moving forward.
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About Duke-Margolis
The Duke-Margolis Center for Health Policy's mission is to improve health and the value of health care through practical, innovative, and evidence-based policy solutions.
This newsletter is published monthly by the Robert J. Margolis, MD, Center for Health Policy at Duke University.
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