Health Information Management

Q/A: Billing for HCPCS code C9291

APCs Insider, April 6, 2012

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Q: We recently read Transmittal 2814 for the April OPPS update. Our question pertains to HCPCS code C9291 (injection, aflibercept, 2 mg vial). Our pharmacists say that each vial contains more than 2 mg; because the vials are single use, the pharmacists want to report the amount that is wasted. The Medicare Claims Processing Manual indicates this is appropriate for single-use vials. We have the necessary documentation.

A: The Medicare Claims Processing Manual, Chapter 17, §40, includes instructions for reporting the amount of waste for drugs supplied in single-use vials that can’t be used.

However, CMS published specific instructions about reporting and reimbursement for code C9291 in Transmittal 281:

Eylea (aflibercept) is packaged in a sterile, 3 mL single use vial containing a 0.278 mL fill of 40 mg/mL Eylea (NDC 61755-0005-02). As approved by the Food and Drug Administration (FDA), the recommended dose for Eylea is 2 mg every 4 weeks, followed by 2 mg every 8 weeks. Payment for HCPCS code C9291 is for the entire contents of the single-use vial, which is labeled as providing a 2 mg dose of aflibercept. As indicated in 42 CFR § 414.904, CMS calculates an ASP payment limit based on the amount of product included in a vial or other container as reflected on the FDA-approved label, and any additional product contained in the vial or other container does not represent a cost to providers and is not incorporated into the ASP payment limit. In addition, no payment is made for amounts of product in excess of that reflected on the FDA-approved label.

CMS notes that the approved FDA dose is 2 mg and by HCPCS code description, that is the lowest reportable unit. CMS further notes that this is the maximum amount of this product that may be reported and reimbursed for this single-use vial. Facilities should not report a wasted amount for any overfill that might be noted on the vial. CMS could create a medically unlikely edit for this HCPCS code.

Editor’s note: Denise Williams, RN, CPC-H, vice president of revenue integrity services at Health Revenue Assurance Associates, Inc., in Plantation, FL, answered this question.



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