HCPCS Code Applications and Approvals: October 2025
Quarterly archive · CMS Level II HCPCS59 coding decisions took effect October 1, 2025
These are the Centers for Medicare and Medicaid Services (CMS) Level II HCPCS drug coding decisions from the Second Quarter 2025 coding cycle, which took effect October 1, 2025.
For the newest decisions, see the current HCPCS code applications and approvals.
CMS Level II HCPCS Drug Coding Decisions
Does not include Q4 skin repair and wound codes.
How to Read This Table
- Action
- CMS decision on the application — establish a new code, revise an existing descriptor, reinstate a code, or discontinue one. See the glossary.
- Code Change
- Where CMS retires a code in favor of another, the new code shows the code it replaces and the retired code shows its replacement.
- 505(b)(2) and Biosimilar
- Tags beside the drug name mark products approved under the FDA 505(b)(2) pathway and biosimilars.
- Effective
- First date of service on which the code may be billed. Codes effective before this quarter reflect retroactive establishment; codes effective after it are decisions CMS scheduled for a later quarter.
October 2025
| HCPCS | Drug & Descriptor | Company | Code Change | Action | Effective |
|---|---|---|---|---|---|
| A9612 | Fluorescein Injection, fluorescein, 1 mg | — | — | Establish | |
| A9616 | GOZELLIX 505(b)(2) Gallium ga-68 gozetotide (gozellix), diagnostic, 1 millicurie | Telix Innovations SA | — | Establish | |
| C9174 | DATROWAY Injection, datopotamab deruxtecan-dlnk, 1 mg | Daiichi Sankyo, Inc. | Replaced byJ9011 | Discontinue | |
| C9175 | GRAFAPEX Injection, treosulfan, 50 mg | Medexus | Replaced byJ0614 | Discontinue | |
| C9248 | Clevidipine Butyrate Injection, clevidipine butyrate, 1 mg | — | Replaced byJ0759 | Discontinue | |
| J0163 | Epinephrine In Sodium Chloride (Endo) Injection, epinephrine in sodium chloride (endo), 0.1 mg | — | — | Establish | |
| J0164 | Epinephrine in Sodium Chloride Injection 505(b)(2) Injection, epinephrine in sodium chloride (baxter), 0.1 mg | Baxter Healthcare Corporation Intravenous | — | Establish | |
| J0458 | EMBLAVEO Injection, aztreonam/avibactam, 7.5 mg/2.5 mg (10 mg) | AbbVie, Inc. Intravenous | — | Establish | |
| J0462 | Atropine Sulfate Injection, atropine sulfate, not therapeutically equivalent to j0461, 0.01 mg | — | — | Establish | |
| J0525 | Cefotetan Disodium 505(b)(2) Injection, cefotetan disodium, 10 mg | — | — | Establish | |
| J0570 | PROBUPHINE Buprenorphine implant, 74.2 mg | ReacX Pharmaceuticals, Inc. | — | Reinstate | |
| J0582 | Bivalirudin (Endo) 505(b)(2) Injection, bivalirudin (endo), not therapeutically equivalent to j0583, 1 mg | — | — | Establish | |
| J0614 | GRAFAPEX Injection, treosulfan, 50 mg | Medexus | ReplacesC9175 | Establish | |
| J0668 | ZYNRELEF 505(b)(2) Instillation, bupivacaine and meloxicam, 1 mg/0.03 mg | Heron Therapeutics, Inc. | — | Establish | |
| J0675 | Carboprost Tromethamine 505(b)(2) Injection, carboprost tromethamine, 0.1 mg | — | — | Establish | |
| J0681 | ZEVTERA Injection, ceftobiprole medocaril sodium, 3 mg | Innoviva Specialty Therapeutics | — | Establish | |
| J0738 | SUNLENCA Injection, lenacapavir, 1 mg, fda approved prescription, only for use as hiv pre-exposure prophylaxis (not for use as treatment for hiv) | Gilead Sciences | — | Establish | |
| J0752 | SUNLENCA Oral, lenacapavir, 300 mg, fda approved prescription, only for use as hiv pre-exposure prophylaxis (not for use as treatment for hiv) | Gilead Sciences | — | Establish | |
| J0759 | Clevidipine Butyrate 505(b)(2) Injection, clevidipine butyrate, 1 mg | — | ReplacesC9248 | Establish | |
| J1370 | Esomeprazole Sodium 505(b)(2) Injection, esomeprazole sodium, 1 mg | — | — | Establish | |
| J1612 | Gvoke VialDx 505(b)(2) Injection, glucagon (gvoke), 0.01 mg | American Regent, Inc. Intravenous | — | Establish | |
| J1807 | Ethacrynate Sodium Injection, ethacrynate sodium, 1 mg | — | — | Establish | |
| J1809 | Fosdenopterin Injection, fosdenopterin, 0.1 mg | — | — | Establish | |
| J1834 | Isoniazid Injection, isoniazid, 1 mg | — | — | Establish | |
| J1961 | SUNLENCA Injection, lenacapavir (only for use as hiv treatment), 1 mg | Gilead Sciences | — | Revise | |
| J2150 | Mannitol Injection, mannitol, 25% in 50 ml | — | Replaced byJ2151 | Discontinue | |
| J2151 | Mannitol 505(b)(2) Injection, mannitol, 250 mg | — | ReplacesJ2150 | Establish | |
| J2291 | Nafcillin Sodium (Baxter) 505(b)(2) Injection, nafcillin sodium (baxter), 20 mg | — | — | Establish | |
| J2503 | Macugen Injection, pegaptanib sodium, 0.3 mg | — | — | Discontinue | |
| J3290 | Tranexamic Acid 505(b)(2) Injection, tranexamic acid, 5 mg | — | — | Establish | |
| J3402 | RYONCIL Injection, remestemcel-l-rknd, per therapeutic dose | Mesoblast. Inc. Intravenous | — | Establish | |
| J3403 | ENCELTO Revakinagene taroretcel-lwey, per implant | Neurotech Pharmaceuticals | — | Establish | |
| J7173 | ALHEMO Injection, concizumab-mtci, 0.5 mg | Novo Nordisk, Inc. Subcutaneous | — | Establish | |
| J7174 | Qfitlia 505(b)(2) Injection, fitusiran, 0.04 mg | Sanofi Subcutaneous | — | Establish | |
| J9011 | DATROWAY Injection, datopotamab deruxtecan-dlnk, 1 mg | Daiichi Sankyo, Inc. | ReplacesC9174 | Establish | |
| J9072 | FRINDOVYX 505(b)(2) Injection, cyclophosphamide (frindovyx), 5 mg | Avyxa Holdings, LLC | — | Revise | |
| Q0235 | AVTOZMA Injection, monoclonal antibody products with an indication for post-exposure prophylaxis or treatment of COVID-19, for hospitalized adults and/or pediatric patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, not otherwise classified, 1 mg | Celltrion USA, Inc. Intravenous | — | Establish | |
| Q0237 | AVTOZMA Injection, tocilizumab-anoh, for hospitalized adult patients with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, 1 mg | Celltrion USA, Inc. Intravenous | — | Establish | |
| Q4383 | Axolotl Graft Ultra Axolotl graft ultra, per square centimeter | Axolotl Biologix Topical | — | Establish | |
| Q4384 | Axolotl DualGraft Ultra Axolotl dualgraft ultra, per square centimeter | Axolotl Biologix Topical | — | Establish | |
| Q4385 | Apollo FT Apollo ft, per square centimeter | Dynamic Medical Services LLC dba Acesso Biologics | — | Establish | |
| Q4386 | Acesso TrifACA Acesso trifaca, per square centimeter | Dynamic Medical Services LLC dba Acesso Biologics | — | Establish | |
| Q4387 | NeoThelium FT Neothelium ft, per square centimeter | Neostim, LLC dba NSM Biologics | — | Establish | |
| Q4388 | NeoThelium 4L Neothelium 4l, per square centimeter | Neostim, LLC dba NSM Biologics | — | Establish | |
| Q4389 | NeoThelium 4L+ Neothelium 4l plus, per square centimeter | Neostim, LLC dba NSM Biologics | — | Establish | |
| Q4390 | Ascendion Ascendion, per square centimeter | Ascension Biologics | — | Establish | |
| Q4391 | AmnioPlast Double Amnioplast double, per square centimeter | Cellution Biologics Inc. | — | Establish | |
| Q4392 | GRAFIX DUO Grafix duo, per square centimeter | Smith and Nephew | — | Establish | |
| Q4393 | SurGraft AC Surgraft ac, per square centimeter | Surgenex, LLC | — | Establish | |
| Q4394 | SurGraft ACA Surgraft aca, per square centimeter | Surgenex, LLC | — | Establish | |
| Q4395 | Acelagraft Acelagraft, per square centimeter | RMBB Health | — | Establish | |
| Q4396 | Natalin Natalin, per square centimeter | RMBB Health | — | Establish | |
| Q4397 | Summit AAA Summit aaa, per square centimeter | Legacy Medical Consultants, LLC | — | Establish | |
| Q5154 | OMLYCLO Biosimilar Injection, omalizumab-igec (omlyclo), biosimilar, 5 mg | Celltrion USA, Inc. Subcutaneous | — | Establish | |
| Q5155 | YESAFILI Biosimilar Injection, aflibercept-jbvf (yesafili), biosimilar, 1 mg | Biocon Biologics Inc. Intravitreal/Ophthalmic | — | Establish | |
| Q5156 | AVTOZMA Biosimilar Injection, tocilizumab-anoh (avtozma), biosimilar, 1 mg | Celltrion USA, Inc. Intravenous | — | Establish | |
| Q5157 | STOBOCLO/OSENVELT Biosimilar Injection, denosumab-bmwo (stoboclo/osenvelt), biosimilar, 1 mg | Celltrion USA, Inc. Subcutaneous | — | Establish | |
| Q5158 | Bomyntra/Conexxence Biosimilar Injection, denosumab-bnht (bomyntra/conexxence), biosimilar, 1 mg | Fresenius Kabi Subcutaneous | — | Establish | |
| Q5159 | OSPOMYV/XBRYK Biosimilar Injection, denosumab-dssb (ospomyv/xbryk), biosimilar, 1 mg | Samsung Bioepis Subcutaneous | — | Establish |
No coding decisions match those filters.
Source: CMS HCPCS application summaries, Second Quarter 2025 coding cycle (PDF) . Data current as of October 7, 2026.
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