Part B Insider (Multispecialty) Coding Alert

Published on Tue Dec 09, 2003 PDF

Drug compendia, studies and documentation all may help gain payment

If your physician is prescribing drugs for uses that aren't approved by the Food & Drug Administration, you could be filling a prescription for hassles.
 
The most common off-label prescriptions are for oncology drugs. A chemotherapy drug "might be tested for lung cancer, but you try it on a prostate cancer," says attorney David Glaser with Fredrickson & Byron
in Minneapolis.
 

"If it's an off-label use, one question that comes up is the extent to which it can be covered under programs like Medicare," says attorney Chris Crosswhite with Duane Morris in Washington. Even if the physician uses her best judgment that the drug will help this patient, the carriers may not include that use of the drug in their local medical review policies or other policies.
 
There's no guarantee of coverage with off-label drugs, but the carriers will apply their usual test: "Is it reasonable and necessary?" Glaser says. "It's no higher risk in my mind."
 
The Medicare Carriers Manual, section 2049.4, says Medicare will cover drugs for an unlabeled use on an incident-to basis if they've been determined to be effective, Glaser says. The carrier will look at sources including the three major drug compendia issued by cancer societies and others to figure out whether the drug should be covered for that use. And the "treating physician rule" says that if a treatment could be reasonable, the carriers should defer to the physician's judgment.
 
Glaser and Crosswhite offer these tips: