The American Society of Echocardiography (ASE) said that it's pleased that the U.S. Food and Drug Administration (FDA) has made positive revisions to the U.S. label for Lantheus Medical Imaging's Definity ultrasound contrast agent.
The removal of the monitoring requirements for Definity will markedly simplify the use of ultrasound contrast from the perspective of both patients and providers and will, along with new safety data on pulmonary hypertension, offer further reassurance to those who are unsure about ultrasound contrast, said Dr. Jonathan Lindner, of Oregon Health & Science University, in a statement.
ASE said it also commends Lantheus for its efforts in helping to clarify the safety and value of contrast as a diagnostic tool, and the society supports the efforts of GE Healthcare to seek similar modifications for its Optison contrast agent. GE plans to submit a label modification request to the FDA later this year, according to ASE.
The society also mentioned developments in its lobbying effort for appropriate reimbursement for contrast administration. In the recently published Medicare Physician Fee Schedule, the U.S. Centers for Medicare and Medicaid Services rejected ASE's request for establishment of additional contrast-enhanced echo ambulatory payment classifications (APCs), but it did increase the APC rate for contrast-enhanced echo by almost $60, according to ASE.
The APC rate for contrast-enhanced transthoracic echocardiography (with spectral and color Doppler) is $164 more than unenhanced procedures under the final rates, but contrast-enhanced stress echocardiography is $23.68 less than unenhanced stress echocardiography, ASE said.
