par Lauren Dubinsky
, Senior Reporter | March 15, 2021
From the March 2021 issue of HealthCare Business News magazine
According to the Petition, the black box warning has led to the reluctance of some physicians to refer patients for CEUS, and some patients are apprehensive about receiving UCAs. The warning is intended to be an indicator of the very highest-level risk associated with FDA-approved products.
Since 2007, the FDA has downgraded package insert contraindications three times and removed a 30-minute monitoring requirement for patients with pulmonary hypertension or unstable cardiopulmonary conditions. Additionally, the agency has recently approved new indications for use in adults and children.
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The major potential adverse reaction associated with UCAs is anaphylaxis, but it’s rare and occurs at a similar or less common rate than this type of reaction to gadolinium agents, according to Back.
“UCAs are primarily cleared from the body through the lungs and do not deposit in the body or burden the kidneys or liver,” she added. “Therefore, renal function does not need to be checked prior to the examination and they can be used in people with compromised renal function as well as those with renal transplants.”
Adoption is on the rise
For more than 40 years CEUS has been in clinical use, although mostly outside of the U.S. until recently. Thanks to continuous advancements in ultrasound technology and UCAs, many radiology practices in the U.S. are now adopting CEUS.
“There are very active national and international basic science and clinical research communities,” said Back. “CEUS studies are routinely presented at major radiology scientific meetings and are published in journals.”
A special issue on CEUS is set to be published soon in the SPR’s official journal, Pediatric Radiology. In addition, both adult and pediatric CEUS courses are currently available, and some educational programs have been added to imaging society meetings.
The lack of appropriate current procedural terminology (CPT) codes has been a hurdle to widespread adoption in the U.S., but things are starting to change. A new “Category I” CPT code for the use of CEUS for non-cardiac abdominal imaging went into effect on January 1, 2019.
Also in 2019, two new CEUS CPT codes were created by the Centers for Medicare and Medicaid Services (CMS). The 76X0X code is for a stand-alone procedure for the evaluation of a single target lesion and the 76X1X code is an add-on for the evaluation of each additional lesion
ICUS keeps abreast with CPT code developments and has compiled all current information, which is available for free on its website.Back to HCB News