Off-label use and reimbursement of contrast media in MR

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.