by
Gus Iversen, Editor in Chief | March 08, 2022
From the March 2022 issue of HealthCare Business News magazine
KD: Before the ultrasound contrast agent in 2016 many providers were slow in implementing off-label use of CEUS. Once the approval came through, we found, through a national survey, that the main bottleneck in advancing pediatric CEUS was the lack of available educational opportunities to start the method. We changed this by implementing through the CPCU educational opportunities, as well as by organizing educational sessions on CEUS at the Society of Pediatric Radiology (SPR) and AIUM annual meetings. Certainly, the COVID-19 pandemic has added a damper to the advancement like many other issues, but it is now picking up.
HCB News: What is the reimbursement situation like for CEUS?
KD: With the approval of the ultrasound contrast agent Lumason, the reimbursement possibility came about. Both the intravenous and intracavitary exams in children are reimbursed. There is a detailed reimbursement explanation of the website of the International Contrast Ultrasound Society (ICUS)
HCB News: Ultrasound contrast has a black box on its label, indicating a high risk of adverse events. Why is there controversy around that?
KD: In 2007 the FDA mandated a black box warning on the package insert of approved UCA in the United States. This black box warning described the possibility of serious cardiopulmonary reactions, including fatalities, following the use of any of the UCAs. A black box warning (or boxed warning) is the strictest labeling requirement that the FDA can issue for medical products. It aims to alert the public and healthcare providers regarding the possibility of serious adverse reactions associated with the use of that product, including serious injury or death. While black box warnings are an important tool for informing the public and can decrease use of medical products in high-risk populations, they may also discourage the use of medical products in people who would benefit from them. The boxed warning for UCA was issued in response to spontaneous reports of a small number of serious adverse events that occurred in adults after UCA administration in the early years of its introduction. However, the reported serious adverse events were not definitely attributed to UCA, and some were later ascribed to underlying medical conditions and/or other medication. Since the issue of the black box warning, cumulative relevant scientific literature continues to show that UCA have a very safe profile. Currently there is an ongoing citizen petition initiative from the ICUS for the removal of the boxed warnings from the UCA product labels.
