Bill correctly for ITVISMA® cell gene therapy drug

In November 2025, the FDA approved ITVISMA® for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients aged two years and older with a confirmed mutation in the survival motor neuron 1 gene. Revenue integrity staff at facilities treating patients with SMA must follow CMS billing guidelines for the new cell gene therapy drug.

Medicare pays for ITVISMA for claims submitted by physician offices with dates of service on or after July 1, 2026. These claims must include Healthcare Common Procedure Coding System (HCPCS) code J3405 (injection, onasemnogene abeparvovec-brve, per treatment) and place of service code 11 (office).

Physician offices should append modifier -LU to identify fractioned billing when submitting multiple claims to bill the treatment amount in increments. Each claim must report 0.1 unit, with charges allocated across the claims to account for the total treatment costs. Modifier -76 indicates a repeat service or payment by the same physician or other qualified healthcare professional, and it should be reported when applicable.

For example, if the total charge for HCPCS code J3405 is $2,729,937.92, the amount would be divided across 30 claims. The office would submit 28 claims with 0.1 unit and a charge of $90,997.93 each, as well as two additional claims with the same unit and a charge of $90,997.94 each.

To prevent billing errors and denials in ITVISMA claims, revenue integrity staff should verify the appropriate codes and modifiers, confirm that each claim reports 0.1 unit, and ensure charges across all claims accurately reflect the total treatment costs.