Billing Guidelines: Fluciclovine F 18 injection, for intravenous use (Axumin), HCPCS Code A4641

Author: CSRA

Effective with date of service, June 1, 2016, the North Carolina Medicaid program covers Axumin for use in the Physician’s Drug Program (PDP) when billed with HCPCS code A4641, radiopharmaceutical, diagnostic, not otherwise classified. Axumin is available in a 30 mL multiple-dose glass vial containing clear, colorless solution of 335-8200 MBq/mL (9-221mCi/mL) fluciclovine F 18 at calibration time and date.

Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is administered with a recommended dose of 370 MBq (10 mCi) as a bolus intravenous injection.

See the package insert for full prescribing information and for detailed instructions on how to prepare fluciclovine F 18 injection.

For Medicaid Billing

  • Providers must bill Axumin with HCPCS code A4641- radiopharmaceutical, diagnostic, not otherwise classified.
  • Providers must indicate the number of HCPCS units (assumption: 1 unit = 1 study dose of 370 MBq [10 mCi]).
  • One Medicaid unit of coverage for Axumin is 1 study dose = 370 MBq (10mCi).
  • Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDC for Axumin is 69932-0001-01.
  • The NDC units should be reported as “UN1.”
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update.
  • For additional information regarding NDC claim requirements related to the PDP, refer to the PDP Clinical Coverage Policy No. 1B, Attachment A, H.7 on Medicaid’s website.
  • Providers shall bill their usual and customary charge for non-340-B drugs.
  • PDP reimburses for drugs billed for Medicaid and NCHC beneficiaries by 340-B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340-B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340-B purchasing agreement by appending the UD modifier on the drug detail.
  • The fee schedule for the PDP is available on Medicaid’s PDP web page.

CSRA 1-800-688-6696

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