May physicians bill Medicare for off-label uses of chemotherapy drugs?
The CMS Manuals; Pub. 100-2; Chapter 15; 50.4.5 provides the National guidelines on the Unlabeled Use for Anti-Cancer Drugs. These guidelines advise that an off-label usage of an FDA approved drug will be considered for coverage when there are no specific contraindications and one of the following criteria is met: A. Its usage is supported by one or more citations in at least one of the three drug compendia listed below, and the usage is not listed as “not indicated” in any of the three compendia: • American Hospital Formulary Service Drug Information • American Medical Association Drug Evaluations • United States Pharmacopoeia Drug Information (USPDI) B. The use is supported by clinical research that appears in peer reviewed medical literature. This applies only when an unlabeled use does not appear in any of the compendia or is listed as insufficient data or investigational. Peer reviewed medical literature includes scientific, medical, and pharmaceutical publications in which origin
The CMS Manuals; Pub. 100-2; Chapter 15; 50.4.5 provides the National guidelines on the Unlabeled Use for Anti-Cancer Drugs. These guidelines advise that an off-label usage of an FDA approved drug will be considered for coverage when there are no specific contraindications and one of the following criteria is met: A. Its usage is supported by one or more citations in at least one of the three drug compendia listed below, and the usage is not listed as “not indicated” in any of the three compendia: • American Hospital Formulary Service Drug Information • American Medical Association Drug Evaluations • United States Pharmacopoeia Drug Information (USPDI) B. The use is supported by clinical research that appears in peer reviewed medical literature. This applies only when an unlabeled use does not appear in any of the compendia or is listed as insufficient data or investigational. Peer reviewed medical literature includes scientific, medical, and pharmaceutical publications in which origin
Related Questions
- Where do physicians find information on off-label uses of FDA approved products and experimental drugs? Where do consumers/patients find the same?
- How does Medicare cover and reimburse anti-cancer drugs administered for an off-label indication?
- May physicians bill Medicare for off-label uses of chemotherapy drugs?
