CMS: ASC Encelto claims use J3403, LU + 76, and 1 unit per eye per day
The August 20, 2026 MLN Connects tells ASCs to bill Encelto as HCPCS J3403 on multiple claims with modifiers LU and 76, and only 1 total unit per eye on a single date of service. Hospital outpatient departments keep normal billing rules.
By the HCC Buddy Coding Team
Published August 20, 2026
Key Takeaways
- →On August 20, 2026, CMS's MLN Connects said Medicare pays for the cell gene therapy drug Encelto for claims with dates of service on or after October 1, 2025, in ambulatory surgical centers and hospital outpatient departments.
- →For ASC Encelto claims, CMS says to submit multiple claims the same way as chimeric antigen receptor T-cell therapy (Medicare Claims Processing Manual, Chapter 32, section 400.2.5) and to append modifier LU (fractionated billing) and modifier 76 (repeat service or payment by the same physician or other qualified health care professional).
- →Hospital outpatient departments follow normal billing rules. The August 20, 2026 MLN does not tell HOPDs to append LU or 76 for Encelto.
- →CMS tells billers to use HCPCS J3403 (revakinagene taroretcel-lwey, per implant) and to bill only 1 total unit of J3403 for a single date of service per eye treatment.
- →CMS's printed example assumes J3403 is $261,579.65 and shows 0.1-unit splits across 10 claims or 0.2-unit splits across 5 claims. That is an example in the MLN, not a published fee schedule.
ASC Encelto claims now have a written CMS method: HCPCS J3403, modifiers LU and 76, multiple claims, and only 1 total unit for a single date of service per eye treatment. CMS put that instruction in the August 20, 2026 MLN Connects under Claims, Pricers & Codes.
Hospital outpatient departments are in the same payment window. They're not on the same claim method. CMS says HOPDs use normal billing rules.
ASC vs HOPD: the split that matters
Medicare pays for the cell gene therapy drug Encelto on claims with dates of service on or after October 1, 2025, in ASCs and hospital outpatient departments. The setting decides the claim build.
| Setting | What the August 20, 2026 MLN says |
|---|---|
| Ambulatory surgical center | Submit multiple claims the same way as chimeric antigen receptor T-cell therapy. Append LU and 76. |
| Hospital outpatient department | Normal billing rules apply. |
Do not copy the ASC modifiers onto an HOPD Encelto line just because the HCPCS is the same. The MLN names LU and 76 only under ASC billing.
How ASC claims are supposed to look
CMS tells ASCs to submit Encelto the same way as CAR-T. The cite is Medicare Claims Processing Manual, Chapter 32, section 400.2.5.
That section is the fractionated-billing method. For Encelto, the MLN names two modifiers only:
- LU: fractionated billing
- 76: repeat service or payment by the same physician or other qualified health care professional
Those parentheticals are CMS's printed wording. Submit multiple claims and append both modifiers. The MLN does not add other CAR-T claim steps for Encelto, so do not invent them from the rest of Chapter 32.
J3403 and the one-unit cap
The HCPCS line is J3403 (revakinagene taroretcel-lwey, per implant). Look it up in the encoder if you want the code next to the other lines you already check.
CMS also sets a hard unit cap: only bill 1 total unit of J3403 for a single date of service per eye treatment. The fractionated claims have to add up to that one unit. They do not create extra units.
The MLN does not name a diagnosis, laterality modifier, or implantation CPT. Stay inside the billing method CMS printed.
CMS's printed dollar example
CMS shows how to split charges if J3403 is $261,579.65. That number is the example in the newsletter. It is not a fee schedule, and it is not a MAC allowed amount you can paste onto a live claim.
| Increment in CMS's example | Number of claims | Units and charges CMS printed |
|---|---|---|
| 0.1 | 10 | Nine claims at 0.1 unit and $26,157.96, plus one claim at 0.1 unit and $26,158.01 |
| 0.2 | 5 | Each claim at 0.2 units and $52,315.93 |
The 0.1 path is 10 claims because nine times $26,157.96 plus one $26,158.01 adds back to $261,579.65. The 0.2 path is five equal $52,315.93 lines. Use your own current allowed amount, then apply the same increment math.
What this is not
It is not an indication. The MLN calls Encelto a cell gene therapy drug and stops there. It does not name a covered diagnosis.
It is not the same newsletter's HCPCS application summaries for non-drug and non-biological items and services (the first biannual 2026 B1 dump). That is a different Claims, Pricers & Codes item.
It is not the January 2027 NCD ICD-10 coding revisions, the FY 2027 IPPS Table 6 files, or the housing Z-code CC-to-NonCC IPPS note. Those are other CMS packets.
It is not a CMS-HCC or V28 model update. If the question is risk adjustment, use the model year you are actually coding in ICD-10 to HCC.
It is not the DMEPOS Competitive Bidding Program Round 2028 fact sheets from the same MLN edition.
What coders should do now
- 1If you bill Encelto from an ASC, set the claim workflow to split J3403 across multiple claims with LU and 76, and stop the batch if the units add up to more than 1 for that eye on that date of service.
- 2If you bill Encelto from a hospital outpatient department, keep normal HOPD billing. Do not copy the ASC LU and 76 split onto HOPD claims just because the HCPCS is the same.
- 3Treat $261,579.65 and the split charges as CMS's printed example only. Pull your current allowed amount from your own pricer or remittance, then apply the same increment math.
- 4Look up J3403 in the [encoder](/encoder) if you need the HCPCS line in the same place you already check codes. This MLN is billing method, not a diagnosis-code change.
- 5If someone asks whether this is a CMS-HCC or V28 update, it is not. Use [ICD-10 to HCC](/icd10-to-hcc) for the model year you are actually coding.
Frequently Asked Questions
Do hospital outpatient departments use LU and 76 for Encelto?
No. The August 20, 2026 MLN Connects says hospital outpatient departments follow normal billing rules. CMS names modifier LU (fractionated billing) and modifier 76 only in the ASC billing instructions.
How many units of J3403 can I bill for one eye on one date of service?
CMS says to bill only 1 total unit of J3403 for a single date of service per eye treatment. Fractionated ASC claims split that one unit; they do not add extra units.
Is $261,579.65 the current Medicare allowed amount for J3403?
No. CMS used $261,579.65 as a printed example of how to split fractionated charges. The August 20, 2026 MLN does not publish a fee schedule amount for J3403.
Does this Encelto billing note change CMS-HCC or V28 mapping?
No. The MLN is ASC and HOPD billing guidance for HCPCS J3403. It is not a CMS-HCC model update and it does not change V28 mappings.
What diagnosis does CMS list for Encelto in the August 20, 2026 MLN?
None. The MLN calls Encelto a cell gene therapy drug and gives the HCPCS, setting, modifier, and unit rules. It does not name an indication or ICD-10-CM code.
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HCC Buddy Coding Team
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