September 22, 2026
Encelto™ Cell Gene Therapy Drug: Billing Guidance
Effective for dates of service on or after October 1, 2025, Medicare pays for the cell gene therapy drug, Encelto, for use in:
- Ambulatory surgical centers (ASCs)
- Hospital outpatient departments (Normal billing rules apply.)
ASC billing instructions:
- Submit claims the same way as chimeric antigen receptor T-cell therapy. See the CMS Medicare Claims Processing Manual (Pub. 100-04), Chapter 32
, section 400.2.5. - Submit multiple claims with:
- HCPCS code J3403 (revakinagene taroretcel-lwey, per implant)
- Modifier LU (fractionated billing)
- Modifier 76 (repeat service or payment by the same physician or other qualified health care professional) for subsequent claims
- Fractionated units (up to 1 unit only for a single date of service per eye treatment)
Examples:
The current payment amount for 1 unit is $261,579.65.
- If you bill in 0.1 increments, split the payment amount to 10 claims.
- Submit 9 claims with 0.1 unit and a charge of $26,157.96.
- Submit 1 claim with 0.1 unit and a charge of $26,158.01.
- If you bill in 0.2 increments, split the payment amount to 5 claims.
- Submit 5 claims with 0.2 units and a charge of $52,315.93.

