Kit for the Preparation of Gallium Ga 68 Gozetotide Injection, for Intravenous Use (Locametz®) HCPCS Code A9597: Billing Guidelines Medicaid and NC Health Choice cover kit for the preparation of gallium Ga 68 gozetotide injection

Effective with date of service March 25, 2022, the Medicaid and NC Health Choice programs covers kit for the preparation of gallium Ga 68 gozetotide injection, for intravenous use (Locametz) for use in the Physician’s Administered Drug Program (PADP) when billed with HCPCS code A9597 - Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified.

Strength/Package Size: Kit for the preparation of gallium Ga 68 gozetotide injection is supplied in a multiple-dose vial containing 25 mcg of gozetotide as a white lyophilized powder. After radiolabeling with gallium-68, the vial contains a sterile solution of gallium Ga 68 gozetotide at a strength up to 1,369 MBq (37 mCi) in up to 10 mL at calibration date and time.

Locametz, after radiolabeling with gallium-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.
• for selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

The recommended amount of radioactivity is 111 MBq to 259 MBq (3 mCi to 7 mCi). Administered as slow intravenous injection. See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

• Providers must bill the product with HCPCS code: A9597 - Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified.
• Providers must indicate the number of HCPCS units  
• One Medicaid and NC Health Choice unit of coverage is: 1 kit
• The maximum reimbursement rate per unit is: $6,048.00
• Providers must bill 11-digit NDCs and appropriate NDC units. The NDC is: 69488-0017-61
• 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