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January 14, 2013 - Updated 09.11.13

Overpayments for Trastuzumab (Herceptin)

An audit by the Office of Inspector General (OIG) of services provided between January 2008 and December 2010 has identified numerous incorrect payments for full vials of Herceptin. Incorrect payments were made as a result of billing errors involving the quantity for an entire multiuse vial versus the dose administered to the specific beneficiary.


Herceptin, also known as trastuzumab, is a Medicare-covered drug used to treat breast cancer that has spread to other parts of the body. Herceptin comes in a multiuse vial of 440 milligrams (mg). A multiuse vial contains more than one dose of medication and is labeled as such by the manufacturer. The manufacturer supplies the drug in a carton containing a multiuse vial of 440 mg of Herceptin and one 20-milliliter vial of bacteriostatic water for injection (BWFI), containing a solution of 1.1 percent benzyl alcohol as a preservative. A vial of Herceptin, when reconstituted with BWFI and stored properly, can be used for up to 28 days.

For multiuse vials, Medicare pays only for the amount administered to a beneficiary and does not pay for any discarded drug. Therefore, a payment for an entire multiuse vial is likely to be incorrect. This audit is part of a nationwide review of the drug Herceptin. The pilot of these reviews found that the Medicare Contractor's payments for full vials of Herceptin were often incorrect.

The OIG reviewed documentation for the specific claims identified. In most cases, payments were found to be incorrect. All of the identified errors were caused when providers reported the units of service for the entire content of one or more vial(s), each containing 440 mg of Herceptin, rather than reporting the units of service for the amount actually administered.

Next steps:

Based on OIG findings, CGS is instructing providers to enter the patient's weight and dosage on the claim notepad. We will periodically review claims for Trastuzumab to ensure this information is being reported and that the dosage is appropriate based on those parameters.

The requirement to enter information into the claim notepad does not replace the requirement to clearly document the treatment regimen, dose given to the patient, and medication administration procedures in the patient's medical record. Should an audit of medical records take place, CGS would expect to find the following:

  1. Beneficiary name and date of service on all documentation
  2. Beneficiary weight used to calculate dose given
  3. Name and amount of drug administered
  4. Signed order for each dose of the drug
  5. Stage of treatment for accurate dose administration calculation for the drug; (i.e., first dose or subsequent dosing)
  6. Documentation of administration of the medication
  7. Legible and complete documentation (including signature(s))
  8. Relevant history (if needed to support medical necessity of administration and amount of drug used)

For more information regarding our analysis of claims for Trastuzumab, please refer to the attached Comparative Billing Reports (CBRs):


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