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Billing for Drugs Split from a Single-Dose Vial

Published on 

Monday, February 23, 2015

 | AL Medicaid 
 | Billing 
 | Outpatient Services 

Recently a hospital reported to MMP that they were cited for an underpayment by the Recovery Auditor because they had billed for a portion of a drug that is only available in a single-dose vial. The hospital, following the appropriate United States Pharmacopeia (USP) standards for compounding, had split the single-dose vial into incremental portions in syringes. They billed Medicare for the dose administered to a patient and the wastage amount of one of the prepared syringes. The RAC denied this as an underpayment – what should the hospital do?

My research revealed that the splitting of single-dose vials is a huge controversy. The Centers for Disease Control and Prevention (CDC) has released a statement opposing the splitting of single-use vials due to safety concerns, except in times of severe shortages of medicines.   CMS has even weighed in on the issue with a memo to the State Survey Agency Directors requiring adherence to strict standards for repackaging of single use vials.

But often single-use vials contain more medication than the routine dose. Drug wastage raises concerns about the high costs of drugs and the ever increasing number of drug shortages. For these reasons, hospital pharmacies may aliquot a single-dose vial into smaller doses. A patient will then be administered the ordered dose from the prepared syringe and any remaining amount within the syringe will be wasted. The hospital should bill for the amount of the drug given and wasted from the single syringe used. This will result in the billing of an amount less than the amount in the single-use vial. Like the situation above, this may cause a Medicare contractor to question your billed units.

The hospital will have to appeal the denial and provide documentation to the contractor that supports:

  • Their process for splitting the single-use vial, including adherence to the required criteria
  • The dosage within the syringe that was used
  • The amount administered to the patient and the amount wasted

If the denial comes from a Recovery Auditor and your hospital has time, you may be able to resolve the issue during the discussion period.

And you probably never thought you would object to an underpayment finding!!

Article Author: Debbie Rubio, BS MT (ASCP)
Debbie Rubio, BS MT (ASCP), was the Manager of Regulatory Affairs and Compliance at Medical Management Plus, Inc. Debbie has over twenty-seven years of experience in healthcare including nine years as the Clinical Compliance Coordinator at a large multi-facility health system. In her current position, Debbie monitors, interprets and communicates current and upcoming regulatory and compliance issues as they relate to specific entities concerning Medicare and other payers.

This material was compiled to share information.  MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.