Neurotech Pharmaceuticals, Inc. has received a permanent J-Code from the Centers for Medicare & Medicaid Services (CMS) for ENCELTO (revakinagene taroretcel-lwey), indicated for the treatment of idiopathic Macular Telangiectasia Type 2 (MacTel).
Let’s first get a refresh on ENCELTO.
This allogeneic encapsulated cell-based gene therapy was granted FDA approval in March 2025.
Its claim to fame: Aside from its groundbreaking status as the first therapeutic approved to treat MacTel—a rare, neurodegenerative retinal disease—ENCELTO is intended to mitigate the risks associated with the most common form of retinal disease treatment: repeated intraocular injections.
How: By controlling the drug dosage that’s delivered to the eye.
Tell me more.
ENCELTO is based on Neurotech’s encapsulated cell therapy (ECT) core platform technology.
What to know about it: Essentially, the ECT platform continuously produces and delivers targeted therapies (either singular or combined) to the back of the eye (the retina) for the long term.
- See here for details on the basis for this platform—the NCT-200 cell line—and how the delivery process works.
Go on …
As for ENCELTO itself, this ocular implant depends on the aforementioned ECT platform to deliver therapeutic doses of ciliary neurotrophic factor (CNTF) into the retina, effectively slowing disease progression.
Check out the clinical data on it—and how it compares to standard intraocular injections.
Let’s talk dosage and precautions.
The recommended dosage: One single-dose implant per affected eye containing 200,000 to 440,000 allogeneic RPE cells expressing recombinant human CNTF (rhCNTF).
- For more details, see its full prescribing information.
A rundown on contraindications as well as warnings and precautions associated with use can be found here.
Speaking of use, have we had any real-world feedback from clinicians yet?
We have, actually.
In fact, just last month Neurotech reported that the first procedure for ENCELTO was performed in Houston, Texas, by Charles C. Wykoff, MD, PhD, of Retina Consultants of Texas.
See here for details on this implantation.
Nice! Now to this J-code … remind me of the meaning behind it.
The basics: A J-code is a permanent reimbursement, Healthcare Common Procedure Coding System (HCPCS)—which standardizes claims for medical services and supplies—Level II code used to designate non-orally administered drugs and other medical devices.
Keep in mind: HCPCS is also used by government payors and commercial insurers to simplify and facilitate the billing and reimbursement process for medical providers’ products and services.
Aren’t there other HCPCS codes?
Indeed; three in total. Here’s a look at them all:
- J-codes (J0120 - J8999) refer to drugs administered via routes that exclude oral methods.
- C-codes (C1713 - 9899) refer to the outpatient prospective patient system (OPPS).
- V-codes (V2020 - V2799) refer to vision services.
And what’s ENCELTO’s new code?
Per CMS: J3403.
Some background: The new code was processed in CMS’s Second Quarter 2025 Drug and Biological HCPCS Level II code application review cycle and is included in its final coding determination (dubbed the October 2025 HCPCS Quarterly Update).
- See page 29 for detail on this submission.
Last question: When is this effective?
Oct. 1.