Use of an approved contrast agent for a clinical purpose not contained in t
he package insert is not in violation of current U.S. Acts providing that i
t is in the course of routine medical practice, not part of an investigatio
n into safety or effectiveness and not commercialized through advertising.
The Food and Drug Administration does not have the authority to regulate th
e use of approved contrast media in any manner that radiologists believe, i
n their professional judgment, would best serve the patient, Moreover, the
use of an approved contrast agent for a clinical purpose not explicitly con
tained in the labeling does not expose the radiologist to malpractice liabi
lity. Regarding reimbursement, there is no guarantee that any payer will re
imburse a provider for use of a contrast agent outside of package insert in
dications, The best way to influence reimbursement is to provide the payer
with detailed information prior to claim submission. (C) 1999 Wiley-Liss, I
nc.