Off-label use and reimbursement of contrast media in MR.

Use of an approved contrast agent for a clinical purpose not contained in the package insert is not in violation of current U.S. Acts providing that it is in the course of routine medical practice, not part of an investigation into safety or effectiveness and not commercialized through advertising. The Food and Drug Administration does not have the authority to regulate the use of approved contrast media in any manner that radiologists believe, in their professional judgment, would best serve the patient. Moreover, the use of an approved contrast agent for a clinical purpose not explicitly contained in the labeling does not expose the radiologist to malpractice liability. Regarding reimbursement, there is no guarantee that any payer will reimburse a provider for use of a contrast agent outside of package insert indications. The best way to influence reimbursement is to provide the payer with detailed information prior to claim submission.