Practice Management Alert

Don't automatically write off off-label drug use in your practice. Payers may frequently deny their reimbursement, but with ample documentation, you may see payment for those frequent and expensive charges. The key to securing off-label drug payment is the documentation you use to support its medical need, safety and acceptability among physicians. Many drugs used or administered in a doctor's office or clinic, especially those for chemotherapy, fall under off-label drug guidelines. They apply not only to drugs that the U.S. Food and Drug Administration (FDA) has not generally approved but also to drugs prescribed or ordered for a different population group such as children instead of adults or at a different dose or duration than that which the FDA approved and reviewed, says Crystal Rice, trade media liaison for the Center for Drug Evaluation and Research at the FDA in Maryland.

If your physician prescribed or ordered an FDA approved drug for a patient belonging to a different population or sub-group deemed to have a favorable risk-benefit ratio, then that drug qualifies as off-label use, Rice says. In this case, you need to follow off-label protocol. Follow This Simple Procedure "Stop, drop and roll" doesn't just protect you from fire it can prevent off-label drug denials that can be as high as $50,000 per claim. If you're charging off-label drugs, Stop your electronic claims submissions, Drop to paper, and Roll in the documentation. This plan is your "best bet" for seeing reimbursement for ordered or prescribed off-label drugs, says Carolyn Davis, CMA, CPC, CCP, CCS-P, CPHT, TMC, the billing supervisor for Oncology Hematology West in Papillion, Neb., and a professional coding and continuing-education instructor at Iowa Western Community College. 1. Stop electronic claims submissions. Electronic claims are your one-way ticket to off-label drug denials. When you submit them, payers will automatically send you either a prepay audit or a denial based on medical necessity, Davis warns. You should also stop electronic submissions for new drugs that you report with unlisted-procedure codes. You'll have a tough time getting paid because the description and national drug code (NDC) may not transmit electronically to your payers, she says. 2. Drop to paper. You will need to submit additional information to get off-label drugs paid, and you can present that information most effectively if you drop your claim to paper at the very beginning, before denials, Davis says. 3. Roll in documentation. There's no two ways around it: You must document the justification for using off-label drugs, and that requirement is substantial. Davis calls documentation the "key piece" to receive payment not only for off-label but also for new drugs. You must provide data from clinical trials that supports off-label drug use. Your [...]