Gadoterate Meglumine Injection, for Intravenous Use (Clariscan™) HCPCS Code A9575: Billing Guidelines Medicaid and NC Health Choice cover gadoterate meglumine injection

Effective with date of service Jan. 1, 2022, the Medicaid and NC Health Choice programs cover gadoterate meglumine injection, for intravenous use (Clariscan) for use in the Physician’s Administered Drug Program (PADP) when billed with HCPCS code A9575 - Injection, gadoterate meglumine, 0.1 mL.

Strengths/Package Sizes: Clariscan Injection is a clear, colorless to yellow solution containing 0.5 mmol/mL of gadoterate meglumine. It is supplied in vials and pre-filled syringes. Clariscan Injection is supplied in 10 mL vials containing 5 mL or 10 mL of solution and in 20 mL vials containing 15 mL or 20 mL of solution. Each single-dose vial is closed with a rubber stopper and sealed with an aluminum cap and the contents are sterile. Vials are packaged in a box of 10, in the following configurations:

• 2.5 mmol per 5 mL (0.5 mmol per mL) in glass vial (NDC 00407-2943-06)
• 5 mmol per 10 mL (0.5 mmol per mL) in glass vial (NDC 00407-2943-01)
• 7.5 mmol per 15 mL (0.5 mmol per mL) in glass vial (NDC 00407-2943-02)
• 10 mmol per 20 mL (0.5 mmol per mL) in glass vial (NDC 00407-2943-05)

Clariscan Injection is supplied in 20 mL plastic pre-filled syringes containing 10 mL, 15 mL, or 20 mL of solution. Each syringe is sealed with rubber closures and the contents are sterile. Syringes, including plunger rod, are individually packaged in a box of 10, in the following configurations:

• 5 mmol per 10 mL (0.5 mmol per mL) in plastic pre-filled syringe (NDC 00407-2943-12)
• 7.5 mmol per 15 mL (0.5 mmol per mL) in plastic pre-filled syringe (NDC 00407-2943-17)
• 10 mmol per 20 mL (0.5 mmol per mL) in plastic pre-filled syringe (NDC 00407-2943-22)

Clariscan Injection Pharmacy Bulk Package is supplied in 100 mL +PlusPak™ (polymer bottle) containing 100 mL of solution.

Each Pharmacy Bulk Package bottle is closed with a rubber stopper and a screw cap and the contents are sterile. Clariscan Pharmacy Bulk Package is packaged in a box of 10, in the following configuration:3

• 50 mmol per 100 mL (0.5 mmol per mL) in +PlusPak™ (polymer bottle) (NDC 00407-2943-70)

Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

The recommended dose of Clariscan is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection at a flow rate of approximately 2 mL/second for adults and 1-2 mL/second for pediatric patients. The dose is delivered by manual or power injection. See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

• Providers must bill the product with HCPCS code: A9575 - Injection, gadoterate meglumine, 0.1 mL.
• Providers must indicate the number of HCPCS units 
• One Medicaid and NC Health Choice unit of coverage is: 0.1 mL
• The maximum reimbursement rate per unit is: $0.15 
• Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 00407-2943-01, 00407-2943-02, 00407-2943-05, 00407-2943-06, 00407-2943-12, 00407-2943-17, 00407-2943-22
• 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