Lutetium Lu 177 Dotatate Injection, for Intravenous Use (Lutathera®), HCPCS Code A9699: Billing Guidelines

Effective with date of service, Aug. 1, 2018, the Medicaid and NC Health Choice programs cover Lutathera for use in the Physician’s Drug Program when billed with HCPCS code A9699, Radiopharmaceutical, therapeutic, not otherwise classified.

Lutathera injection containing 370 MBq/mL (10 mCi/ml) of lutetium Lu 177 dotatate is a sterile, preservative-free solution for intravenous use supplied in a colorless Type I glass 30 mL single-dose vial containing 7.4 GBq (200 mCi) ± 10% of lutetium Lu 177 dotatate at the time of injection. The solution volume in the vial is adjusted from 20.5 mL to 25 mL to provide a total of 7.4 GBq (200 mCi) of radioactivity.

Lutathera is a radiolabeled somatostatin analog indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

The recommended dose of Lutathera is 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses.

See the package insert for important safety information and full prescribing and administration information.

For Medicaid and NC Health Choice Billing

• Providers must bill the product with HCPCS code: A9699 - Radiopharmaceutical, therapeutic, not otherwise classified
• Providers must indicate the number of HCPCS units
• One Medicaid unit of coverage is: 1 vial
• The maximum reimbursement rate per unit is: $51,300.00 per 1 vial
• Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDC is: 69488-0003-01
• 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-340B drugs.
• PDP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
• The fee schedule for the Physician's Drug Program is available on Medicaid's PDP web page.