Note: This bulletin has been revised to correct the maximum reimbursement rate per unit of $1,015.20 of mCi amount of drug infused.
Effective with date of service, July 1, 2022, Medicaid and NC Health Choice programs covers kit for the preparation of Gallium Ga 68 gozetotide injection, for intravenous use (Illuccix) for use in the Physician’s Administered Drug Program (PADP) when billed with HCPCS code A9596.
Illuccix is supplied as a kit for preparing Gallium Ga 68 gozetotide Injection. There are two different kit configurations, each containing three vials.
Illuccix Configuration “A” (NDC 74725-100-25) is intended for use with Ga 68 produced from a cyclotron and purified via GE FAST lab or Eckert & Ziegler GalliaPharm Ge 68/Ga 68 generator and includes:
- Vial 1 (Gozetotide Vial): contains 25 mcg gozetotide and 10 mcg D-mannose as a lyophilized powder in a sterile 10 mL vial with a blue flip-off cap (NDC 74725-101-25).
- Vial 2 (Acetate Buffer Vial, Configuration A): contains 150 mg anhydrous sodium acetate in 0.292 M HCl solution (2.5 mL volume) in a sterile 10 mL vial with a red flip off cap (NDC 74725-102-25).
- Vial 3 (Sterile Vacuumed Reaction Vial): an evacuated sterile vial with white flip off cap used to collect Ga 68 chloride from generators or cyclotron and radiolabeling reaction; a multiple-dose vial after radiolabeling.
Illuccix Configuration “B” (NDC 74725-100-64) is intended for use with Ga 68 produced from an IRE Galli Eo Ge 68/Ga 68 generator and includes:
- Vial 1 (Gozetotide Vial): contains 25 mcg gozetotide and 10 mcg D-mannose as a lyophilized powder in a sterile 10 mL vial with a blue flip-off cap (NDC 74725-101-25).
- Vial 2 (Acetate Buffer Vial, Configuration B): contains 150 mg anhydrous sodium acetate in 0.175 M HCl solution (6.4 mL volume) in a sterile 10 mL vial with a green flip off cap (NDC 74725-103-64)
- Vial 3 (Sterile Vacuumed Reaction Vial): an evacuated sterile vial with white flip off cap used to collect Ga 68 chloride from generator and radiolabeling reaction; a multiple-dose vial after radiolabeling.
Illuccix, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection. See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing
- Providers must bill the product with HCPCS code: A9596 - Gallium Ga-68 gozetotide, diagnostic, (illuccix), 1 millicurie.
- Providers must indicate the number of HCPCS units
- One Medicaid and NC Health Choice unit of coverage is: 1 millicurie
- The maximum reimbursement rate per unit is: $ 1,015.20
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 74725-0100-25, 74725-0100-64
- The NDC units should be reported as “UN1”
- For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
- Providers shall bill their usual and customary charge for non-340B drugs
- PADP 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 PADP is available on Medicaid's PADP web page.
Contact
NCTracks Call Center: 800-688-6696