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 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 400.2.5
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