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Thread: Off Label use of Drug and billing patient

  1. #1

    Unhappy Off Label use of Drug and billing patient

    AAPC: Back to School
    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.

  2. #2
    Join Date
    Apr 2007


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

    Laura, CPC, CEMC

  3. #3


    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

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

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