Providers Should Be Careful to Not Overbill for Multi-Dose Vials of Herceptin

Hospitals and other provider should take care to properly bill for Herceptin, a medication that treats breast cancer once it has spread to other parts of the body.  The Office of the Inspector General (OIG) found that during a two-year period nearly 14 percent of claims paid by one Medicare contractor were for full vials of Herceptin resulting in overpayments of nearly $2.4 million dollars. 

Herceptin comes in multi-dose vials.  Each vial contains 44 billable doses. Medicare pays only for the amount administered to the beneficiary and does not pay for any discarded amounts. So if one or two patients come into a facility to receive a dose of Herceptin, there are several more billable doses left in the vial. Those doses can be used on other patients or properly stored for use at a later date. CMS has advised physicians and other providers to schedule patients to whom Herceptin is to be administered for consecutive appointments to lessen the chance that doses will be discarded.  A vial of Herceptin can be stored for 28 days.  A vial of the medication that is stored can be reconstituted with bacteriostatic water which is provided with the medication.

Improper Billings

The OIG looked at claims for Herceptin in one Medicare contractor’s jurisdiction that were for one vial or in units of multiples of 44 as there are 44 doses of the medication per vial.  There were 51 providers who submitted 1,985 claims for a full vial of Herceptin of units in multiples of 44 in that jurisdiction during the two years studied.  These providers had billed Medicare for 44 to 264 units of the drug rather than the actual amount administered.  In these cases, the providers submitted claims for amounts that had been discarded. In interviews with the providers, OIG determined that these vials were not properly reconstituted by the providers pharmacies.  The pharmacies had used sterile water instead of bacteriostatic water to reconstitute the medication. Using sterile water makes it not possible to save the remaining doses in the vial for future use. The OIG reported that as of the writing of their report, providers had refunded $131,461 of the $2.3 million in overpayments that were a result of improper billing for the discarded medication.  The OIG discovered that an additional $133,268 was over paid as a result of providers not having any supporting documentation for 44 claims for the administration of Herceptin.  Those providers have submitted adjusted claims to refund the overpaid amount.


In addition to having the overpayment amount refunded, the OIG recommended that the edits be developed for the Fiscal Intermediary Standard System and the Common Working File to detect and prevent payments for full vials of Herceptin or claims for Herceptin in multiples of 44.  Without those, edits CMS is relying on providers to modify Medicare contractors of incorrect payments made on behalf of beneficiaries.