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October 21, 2025

Billing for Encelto™ in the ASC Setting

Medicare approved a groundbreaking new cell gene therapy drug, Encelto™ for use in the Ambulatory Surgical Center (ASC) setting only.

Due to the high cost of this drug, ASCs must submit multiple claims to facilitate proper payment.

Billing instructions

Report the following on each claim:

  • Date of service on or after October 1, 2025
  • An appropriate surgical procedure code from the ASC Fee Schedule
  • HCPCS code J3403 (revakinagene tarorectcel-lwey, per implant)
    • Modifier LU (fractionated billing)
    • Modifier 76 (repeat service or payment by the same physician or other qualified healthcare professional) for subsequent claims
    • 0.1 fractionated units x 10 = 1 unit (total Medicare allowed payment amount)

Billing example

If the allowed payment for 1 unit is $250,000.00:

  • Claim 1 – 0.2 units = $50,000
  • Claim 2 – 0.2 units = $50,000
  • Claim 3 – 0.2 units = $50,000
  • Claim 4 – 0.2 units = $50,000
  • Claim 5 – 0.2 units = $50,000

Claim 1 example

Claim 1 Example

Claim 2-5 example

Claim 2-5 Example

These billing instructions are the same as chimeric antigen receptor T-cell therapy. See the CMS Medicare Claims Processing Manual (Pub. 100-04), chapter 32, section 400.2.5External PDF.

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