J3399 — Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5x10^15 vector genomes
J3399 is a HCPCS Level II code for injection, onasemnogene abeparvovec-xioi, per treatment, up to 5x10^15 vector genomes. It belongs to the Drugs Administered Other Than Oral Method section. Whether Medicare pays it depends on the coverage rule below.
Medicare coverage: Carrier judgment
Coverage is decided by your Medicare contractor, not by national policy. Whether this is paid depends on the LCD for your jurisdiction and on what the documentation supports.
From the coverage field of the CMS Alpha-Numeric HCPCS File, release 2026Q3-Jul. This states Medicare’s position on the code, not on your particular claim.
Physician fee schedule statusE
Excluded from the physician fee schedule by regulation. Payment, where it exists, comes from another fee schedule (drugs via ASP, supplies via DMEPOS, and so on).
Global period: XXX
Want the dollar amount for your locality? The fee calculator applies your GPCI and the current conversion factor.
Medically Unlikely Edits — units per day
The most units of J3399 Medicare will pay on one date of service. Bill more on a single line and it is denied. The limit is not the same in every setting, so the row that matters is the one matching the claim you are building.
- practitioner
- 1 unit MAI 3 — Date of Service Edit: Clinical · Prescribing Information
- outpatient
- 1 unit MAI 3 — Date of Service Edit: Clinical · Prescribing Information
The adjudication indicator decides whether exceeding the limit is worth appealing at all: MAI 1 is a line edit you can support with documentation, MAI 3 is a date-of-service edit that is also appealable, and MAI 2 is absolute — no documentation overrides it. CMS MUE 2026Q3.
The CMS record for J3399
- Long descriptor
- Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5x10^15 vector genomes
- Short descriptor
- Inj onase abepar-xioi treat
- Added
- July 1, 2020
- BETOS
- O1E
- Pricing indicator
- 51 — Other
The official wording. This is what the code means.
CMS's 28-character form, which is what shows up on a remittance advice.
When CMS introduced the code.
Berenson-Eggers Type of Service — CMS's own analytic grouping.
Drugs.
Codes adjacent to J3399
HCPCS has no hierarchy — related items simply sit next to each other in the numbering. If J3399 is not quite right, the correct code is very often within a few positions of it.
- J3389Topical administration, prademagene zamikeracel, per treatment
- J3391Injection, atidarsagene autotemcel, per treatment
- J3392Injection, exagamglogene autotemcel, per treatment
- J3393Injection, betibeglogene autotemcel, per treatment
- J3394Injection, lovotibeglogene autotemcel, per treatment
- J3396Injection, verteporfin, 0.1 mg
- J3397Injection, vestronidase alfa-vjbk, 1 mg
- J3398Injection, voretigene neparvovec-rzyl, 1 billion vector genomes
- J3400Injection, triflupromazine hcl, up to 20 mgterminated
- J3401Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml
- J3402Injection, remestemcel-l-rknd, per therapeutic dose
- J3403Revakinagene taroretcel-lwey, per implant
- J3404Injection, zopapogene imadenovec-drba suspension, per therapeutic dose
- J3405Injection, onasemnogene abeparvovec-brve, per treatment
- J3410Injection, hydroxyzine hcl, up to 25 mg
- J3411Injection, thiamine hcl, 100 mg
Questions about J3399
What is HCPCS code J3399?
J3399 is a HCPCS Level II code for injection, onasemnogene abeparvovec-xioi, per treatment, up to 5x10^15 vector genomes. It sits in the Drugs Administered Other Than Oral Method section.
Does Medicare cover J3399?
The CMS HCPCS file marks J3399 as "Carrier judgment". Coverage is decided by your Medicare contractor, not by national policy. Whether this is paid depends on the LCD for your jurisdiction and on what the documentation supports.
How is J3399 paid under the physician fee schedule?
J3399 carries PFS status code E. Excluded from the physician fee schedule by regulation. Payment, where it exists, comes from another fee schedule (drugs via ASP, supplies via DMEPOS, and so on).