J9345 — Injection, retifanlimab-dlwr, 1 mg
J9345 is a HCPCS Level II code for injection, retifanlimab-dlwr, 1 mg. 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 J9345 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
- 500 units MAI 3 — Date of Service Edit: Clinical · Prescribing Information
- outpatient
- 500 units 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 J9345
- Long descriptor
- Injection, retifanlimab-dlwr, 1 mg
- Short descriptor
- Inj, retifanlimab-dlwr, 1 mg
- Added
- October 1, 2023
- BETOS
- O1D
- 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 J9345
HCPCS has no hierarchy — related items simply sit next to each other in the numbering. If J9345 is not quite right, the correct code is very often within a few positions of it.
- J9330Injection, temsirolimus, 1 mg
- J9331Injection, sirolimus protein-bound particles, 1 mg
- J9332Injection, efgartigimod alfa-fcab, 2mg
- J9333Injection, rozanolixizumab-noli, 1 mg
- J9334Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc
- J9340Injection, thiotepa, 15 mgterminated
- J9341Injection, thiotepa (tepylute), 1 mg
- J9342Injection, thiotepa, not otherwise specified, 1 mg
- J9347Injection, tremelimumab-actl, 1 mg
- J9348Injection, naxitamab-gqgk, 1 mg
- J9349Injection, tafasitamab-cxix, 2 mg
- J9350Injection, mosunetuzumab-axgb, 1 mg
- J9351Injection, topotecan, 0.1 mg
- J9352Injection, trabectedin, 0.1 mg
- J9353Injection, margetuximab-cmkb, 5 mg
- J9354Injection, ado-trastuzumab emtansine, 1 mg
Questions about J9345
What is HCPCS code J9345?
J9345 is a HCPCS Level II code for injection, retifanlimab-dlwr, 1 mg. It sits in the Drugs Administered Other Than Oral Method section.
Does Medicare cover J9345?
The CMS HCPCS file marks J9345 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 J9345 paid under the physician fee schedule?
J9345 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).