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2026-08-20 - Encelto™ Cell Gene Therapy Drug: Get Billing Guidance
Act
by Oct 1, 2025
Effective date
Oct 1, 2025
Identified
Sep 29, 2026
Summary
Medicare now covers Encelto™ (revakinagene taroretcel-lwey), a cell gene therapy drug, effective October 1, 2025, for use in ASCs and hospital outpatient departments. Billing teams must submit claims using HCPCS code J3403 with fractionated billing using LU and 76 modifiers, splitting the total drug cost across multiple claims in 0.1 or 0.2 unit increments, with a maximum of 1 total unit billed per eye treatment per date of service.
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What to do
by Oct 1, 2025 · 7 steps
01Billing team must update billing system and workflows to implement fractionated billing for HCPCS code J3403.
02Configure system to split J3403 charges across multiple claims using either 0.1 unit increments (10 claims) or 0.2 unit increments (5 claims) based on total drug cost.
03Require LU modifier (fractionated billing) and 76 modifier (repeat service) on all J3403 claims.
04Enforce limit of 1 total unit of J3403 per single date of service per eye treatment.
05Update encounter forms and billing instructions to identify when Encelto is administered in ASCs or hospital outpatient departments.
06Train billing staff on chimeric antigen receptor T-cell therapy billing rules per Medicare Claims Processing Manual Chapter 32, section 400.2.5.
07Claims submitted without proper fractionation, modifiers, or exceeding the 1-unit limit per eye per DOS will be denied.
Codes mentioned
J3403
Original notice
2026-08-20 - Encelto™ Cell Gene Therapy Drug: Get Billing Guidance
cms.gov · Always check the source before changing claims.