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There are many legal and policy issues raised by the FDA notice on regulating some imaging agents that meet both the device and drug definition as devices. The potential impacts are not only to the companies which are market lawful with FDA approved imaging drugs - including contrast media and radiopharmaceuticals - but to healthcare providers, pharmacies, supply chain managers, distributors, and patients. The MarkeTech Group recently surveyed our imagePRO™ panel to gauge their opinions on the recent FDA notice.

Disruptions in the pharmaceutical supply chain critical to radiologic imaging has impacted the global availability of iohexol iodinated contrast media (ICM) which may affect the ability of radiology departments to provide health care to patients needing contrast-enhanced exams. The MarkeTech Group recently surveyed its imagePRO™ panel to get radiology administrators’ opinions on how the iodinated contrast agent shortage in the USA may impact the imaging service line. The current impact of the iodinated contrast agent shortage is not extremely high 25% of radiology administrators say they are very to extremely impacted due to iodinated contrast shortage used in CT and X-ray exams, while another 22% say that they are moderately impacted. Respondents who state that they are somewhat impacted has the highest share at 28%, while 24% are not impacted from iodinated contrast shortage at all Most centers defined a strategy to mitigate the impact of the iodinated contrast agent shortage Overall, only 12% of respondents state that they have not defined strategy to mitigate the impact of the iodinated contrast agent shortage or defined protocols to operate under a contrast shortage. The vast majority (63%) indicated that they have already defined and implemented such strategies or protocols, while another 25% say that they have protocols and strategies planned but not implemented yet. Iodinated contrast agent shortage is expected to increase MRI utilization While the iodinated contrast agent shortage used in CT and X-ray exams will negatively impact the utilization of these two imaging modalities, for some exams there could be alternative modalities suitable for utilization. 59% of respondents expect to see an increase in MRI utilization due to the iodinated contrast agent shortage, another 26% expect an increase in ultrasound utilization, while 13% do not think the shortage would increase utilization of other imaging modalities

Value-based care is a concept that was introduced into the healthcare system over 50 years ago (Novikov D, 2018)