Published February 7, 2012

OIG Audits of the drug Herceptin (Trastuzumab)

As part of the Office of the Inspector General’s (OIG) 2012 Work Plan, organizations are already receiving letters related to Medicare claims under review for the chemotherapy drug, Herceptin. The purpose of the (OIG) review is to determine whether reimbursement was appropriate.

Specific line items are being extracted from the Centers for Medicare & Medicaid Services’ (CMS) National Claim History file for the period January 1, 2008 through December 31, 2010, where the Healthcare Common Procedure Coding System (HCPCS) code J9355 was charged with unit counts of multiples of 44 (44, 88, 132, etc.) or the payment exceeded $10,000.

Why the focus on Herceptin? Unlike single-use vials, where the hospital is reimbursed for both the administered amount as well as the discarded amount after administering a dose, Herceptin is manufactured in a multi-use vial. Medicare will not reimburse the discarded amount for the multi-use vial of Herceptin.

Medicare pays $71.76 per 10 mg of Herceptin under the Outpatient Prospective Payment System (OPPS), and medical necessity is determined by the type of cancer. Every 10 mg unit charged for unused Herceptin could result in a Medicare overpayment of $71.76. For example, 300 mg of unused Herceptin translates to 30 units and could result in a Medicare overpayment of $2,152.80 (for a single-patient claim). The good news is that unexpired multi-use vials of Herceptin can be administered to additional patients, and therefore charged and billed.

The focus of the OIG audit examines if HCPCS J9355 has been billed accurately with the correct administered units and supporting documentation. Hospitals are being asked to research and report the following:

  • If the drug was administered, note the actual dosage administered (e.g., 10 mg) and whether the number of units billed for Herceptin was correct
  • If the service was billed in error, describe what service was actually performed and the correct number of units that should have been billed
  • Documentation that supports:
    • Medical necessity of the medication
    • Physician’s order for the medication
    • Medication administration
    • Type of solution used to reconstitute the Herceptin (Bacterisotatic water containing 1.1 percent benzyl alcohol or sterile water)
  • Controls in place, if any, that ensure that overpayments resulting from erroneous charges are identified and refunded to the Medicare program and beneficiary.

If you would like additional information on the Herceptin OIG review, or other compliance topics, please contact the experts listed below at PYA, (800) 270-9629.

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