# Off Label use of Drug and billing patient



## diahanne (Sep 22, 2009)

I would appreciate anyones help who can direct me to the page on Medicare's website that states something like this.  When a drug is used for a non approved off lablel diagnosis, we will not pay for the DRUG OR ADMINISTRATION of the drug.

I had this before and this question is rearing its ugly little head again and I can not find the information to prove my point.


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## LLovett (Sep 22, 2009)

Check the OIG website, they just slammed Pfizer for this.

Laura, CPC, CEMC


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## ANGELAMM2004 (Nov 5, 2009)

Excerpts from CMS internet only Manual (IOM):
*Publications 100-02 Medicare Benefit Policy Manual: Chapter 15 Section 50.4.5 - Unlabeled Use for
Anti-Cancer Drugs
If a use is identified as not indicated by CMS or the FDA or if a use is specifically identified as not
indicated (in one or more of the three compendia mentioned) or if it is determined (based on peer
reviewed medical literature) that a particular use of a drug is not safe and effective, the off-label usage is
not supported and, therefore, the drug is not covered. In this instance, the administration is also not
covered.*

However, keep in mind that reviewed medical literature can sometime overturn the compedia. Thanks, Angela


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