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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 32External PDF, 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.

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