Unproven Medical Treatments Cost Us Lives and Money. Let Research Tell Us What Works.
(1/11, Ezekiel J. Emanuel and Justin E. Bekelman, USA Today) comments “...[I]nsurers should pay for unproven treatments only when received through studies. Specifically, while the intervention is being tested, insurers and government programs should set the price of new treatments equal to the current standard of care, a model known as reference pricing. The price should be reset only if research ultimately shows better (or worse) outcomes. This approach promotes both access and innovation. The University of Pennsylvania already does this for proton therapy and has arranged with some insurers to review cases within 24 hours.” Full
FDA to Beef Up Sentinel Postmarket Safety System
(1/11, Susan Kelly, BioPharma DIVE) reports “...In a statement announcing the agency's strategy for expanding Sentinel, FDA Commissioner Scott Gottlieb and Gerald Dal Pan, director of the agency's Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research, said greater use of real world evidence can improve patient outcomes and lower the cost of medical product development...In addition to developing approaches to identify unexpected safety concerns, the agency is working with the National Institutes of Health Collaboratory Distributed Research Network and the Patient Centered Outcomes Research Network to develop the Sentinel data infrastructure for other public health purposes.” Full
NAACOS and ACO Leaders Express Distress Over Just-Announced MSSP Application Deadline
(1/11, Mark Hagland, Healthcare Informatics) reports “...NAACOS stated that ‘[CMS] late Wednesday announced applications to participate in the new Pathways to Success accountable care organization program will be due February 19, two months after the agency published a nearly 267-page rule overhauling the Medicare Shared Savings Program. In response, the National Association of ACOs is calling on CMS to give ACOs till later in March to understand the complex changes and determine participation options with affiliated doctors, hospitals, and other providers before committing to high-stakes decisions.’” Full
Ireland: Updated Guidelines to Improve HTAs Accuracy
(1/11, Valerie Ryan, Irish Medical Times) reports “...Dr Conor Teljeur, HIQA's Chief Scientist, said: ‘A considerable proportion of the health budget each year is invested in new technologies and programmes. Funding decisions should be based on sound evidence, and there should be reassurance that those decisions will deliver care that is both patient-focused and achieves value for money. Health technology assessment provides a framework for a comprehensive evaluation of the evidence. A critical element is how clinical outcomes are evaluated in a HTA, and these guidelines show how this can be achieved,’ he added.” Full
Measuring the Value of MRI: Comparative Effectiveness & Outcomes Research
Stella K. Kang MD, MSc
January 10, 2019, Journal of Magnetic Resonance Imaging
Do Interventions That Address Patient Cost-Sharing Improve Adherence to Prescription Drugs? A Systematic Review of Recently Published Studies Sensharma A, Yabroff KR.
January 10, 2019, Expert Review of PharmacoEconomics and Outcomes Research
Requests for Comment
Tools and Technologies for Registry Interoperability
January 11 - February 8, 2019