HCPCS Code Applications and Approvals: January 2026
Quarterly archive · CMS Level II HCPCS47 coding decisions took effect January 1, 2026
These are the Centers for Medicare and Medicaid Services (CMS) Level II HCPCS drug coding decisions from the Third Quarter 2025 coding cycle, which took effect January 1, 2026.
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.
January 2026
| HCPCS | Drug & Descriptor | Company | Code Change | Action | Effective |
|---|---|---|---|---|---|
| C9305 | IMAAVY Injection nipocalimab-aahu, 3 mg | Johnson & Johnson Healthcare Systems, Inc. Intravenous | Replaced byJ9256 | Discontinue | |
| C9306 | EMRELIS Injection telisotuzumab vedotin-tllv, 1 mg | AbbVie Intravenous | Replaced byJ9326 | Discontinue | |
| J0013 | Esketamine 505(b)(2) Esketamine, nasal spray, 1 mg | — | — | Establish | |
| J0162 | Epinephrine 505(b)(2) Injection, epinephrine (fresenius), not o therapeutically equivalent to j0165, 0.1 mg | Fresenius Kabi Intramuscular/Intravenous | — | Establish | |
| J0654 | Liothyronine 505(b)(2) Injection, liothyronine, 1 mcg | — | — | Establish | |
| J1073 | Testosterone Pellet Testosterone pellet, implant, 75 mg | — | — | Establish | |
| J1736 | Qamzova 505(b)(2) Injection, meloxicam (delova), 1 mg | Delova Biotech Inc. Intravenous | — | Establish | |
| J1737 | XIFYRM 505(b)(2) Injection, meloxicam (azurity), 1 mg | Azurity Pharmaceuticals, Inc. Intravenous | — | Establish | |
| J1837 | Posaconazole 505(b)(2) Injection, posaconazole, 1 mg | — | — | Establish | |
| J2516 | Pentamidine Isethionate 505(b)(2) Injection, pentamidine isethionate, 1 mg | — | — | Establish | |
| J2596 | Vasopressin (Long Grove) 505(b)(2) Injection, vasopressin (long grove), not therapeutically equivalent to j2598, 1 unit | — | — | Establish | |
| J2711 | Neostigmine Methylsulfate 0.1 Mg and Glycopyrrolate 0.02 Mg Injection, neostigmine methylsulfate 0.1 mg and glycopyrrolate 0.02 mg | — | — | Establish | |
| J3291 | Tranexamic Acid In Sodium Chloride 505(b)(2) Injection, tranexamic acid in sodium chloride, 5 mg | — | — | Establish | |
| J3376 | Vancomycin Hcl (Hikma) Injection, vancomycin hcl (hikma), not therapeutically equivalent to j3373, 10 mg | — | — | Establish | |
| J3379 | Valproate Sodium Injection, valproate sodium, 5 mg | — | — | Establish | |
| J3387 | Elivaldogene Autotemcel 505(b)(2) Injection, elivaldogene autotemcel, per treatment | — | — | Establish | |
| J3389 | ZEVASKYN Topical administration, prademagene zamikeracel, per treatment | Abeona Therapeutics Topical | — | Establish | |
| J7299 | MIUDELLA Copper Intrauterine System Intrauterine copper contraceptive (miudella) | Sebela Women's Health Inc. | — | Establish | |
| J7322 | HYMOVIS ONE Hyaluronan or derivative, hymovis or hymovis one, for intra-articular injection, 1 mg | Fidia Pharma USA Inc. Intra-articular | — | Revise | |
| J7528 | Mycophenolate Mofetil Mycophenolate mofetil, for suspension, oral, 100 mg | — | — | Establish | |
| J9184 | AVGEMSI 505(b)(2) Injection, gemcitabine hydrochloride (avyxa), 200 mg | AVYXA Pharma, LLC Intravenous | — | Establish | |
| J9256 | IMAAVY Injection, nipocalimab-aahu, 3 mg | Johnson & Johnson Healthcare Systems, Inc. Intravenous | ReplacesC9305 | Establish | |
| J9282 | ZUSDURI Mitomycin, intravesical instillation, 1 mg | UroGen Pharma, Inc. Intravesical | — | Establish | |
| J9326 | EMRELIS Injection, telisotuzumab vedotin-tllv, 1 mg | AbbVie Intravenous | ReplacesC9306 | Establish | |
| Q4354 | Dual Layer PalinGen X-Membrane Palingen dual-layer membrane and dual-layer palingen x-membrane, per square centimeter (add-on, list separately in addition to primary procedure) | Amnio Technology | — | Revise | |
| Q4398 | Summit AC Summit ac, per square centimeter (add-on, list separately in addition to primary procedure) | Legacy Medical Consultants | — | Establish | |
| Q4399 | Summit FX Summit fx, per square centimeter (add-on, list separately in addition to primary procedure) | Legacy Medical Consultants | — | Establish | |
| Q4400 | Polygon3 Membrane Polygon3 membrane, per square centimeter (add-on, list separately in addition to primary procedure) | Amnio Technology | — | Establish | |
| Q4401 | Absolv3 Membrane Absolv3 membrane, per square centimeter (add-on, list separately in addition to primary procedure) | Amnio Technology | — | Establish | |
| Q4402 | XWRAP 2.0 Xwrap 2.0, per square centimeter (add-on, list separately in addition to primary procedure) | Applied Biologics | — | Establish | |
| Q4403 | XWRAP Dual Plus Xwrap dual plus, per square centimeter (add-on, list separately in addition to primary procedure) | Applied Biologics | — | Establish | |
| Q4404 | XWRAP Hydro Plus Xwrap hydro plus, per square centimeter (add-on, list separately in addition to primary procedure) | Applied Biologics | — | Establish | |
| Q4405 | XWRAP Fenestra Plus Xwrap fenestra plus, per square centimeter (add-on, list separately in addition to primary procedure) | Applied Biologics | — | Establish | |
| Q4406 | XWRAP Fenestra Xwrap fenestra, per square centimeter (add-on, list separately in addition to primary procedure) | Applied Biologics | — | Establish | |
| Q4407 | XWRAP Tribus Xwrap tribus, per square centimeter (add-on, list separately in addition to primary procedure) | Applied Biologics | — | Establish | |
| Q4408 | XWRAP Hydro Xwrap hydro, per square centimeter (add-on, list separately in addition to primary procedure) | Applied Biologics | — | Establish | |
| Q4409 | AmnioMatrixF3X Amniomatrixf3x, per square centimeter (add-on, list separately in addition to primary procedure) | Cellution Biologics Inc. | — | Establish | |
| Q4410 | AmchoMatrixDL Amchomatrixdl, per square centimeter (add-on, list separately in addition to primary procedure) | Cellution Biologics Inc. | — | Establish | |
| Q4411 | AmnioMatrixF4X Amniomatrixf4x, per square centimeter (add-on, list separately in addition to primary procedure) | Cellution Biologics Inc. | — | Establish | |
| Q4412 | CHORIOFIX Choriofix, per square centimeter (add-on, list separately in addition to primary procedure) | MiMedx | — | Establish | |
| Q4413 | CYGNUS Solo Cygnus solo, per square centimeter (add-on, list separately in addition to primary procedure) | Vivex Biologics | — | Establish | |
| Q4414 | SimpliChor Simplichor, per square centimeter (add-on, list separately in addition to primary procedure) | Xtant Medical | — | Establish | |
| Q4415 | AlexiGuard SL-T Alexiguard sl-t, per square centimeter (add-on, list separately in addition to primary procedure) | AlexiGen BioTech | — | Establish | |
| Q4416 | AlexiGuard TL-T Alexiguard tl-t, per square centimeter (add-on, list separately in addition to primary procedure) | AlexiGen BioTech | — | Establish | |
| Q4417 | AlexiGuard DL-T Alexiguard dl-t, per square centimeter (add-on, list separately in addition to primary procedure) | AlexiGen BioTech | — | Establish | |
| Q4420 | NuForm Nuform, per square centimeter (add-on, list separately in addition to primary procedure) | Organogenesis Inc. | — | Establish | |
| Q5160 | JOBEVNE Biosimilar Injection, bevacizumab-nwgd (jobevne), biosimilar, 10 mg | Biocon Biologics Inc. Intravenous | — | Establish |
No coding decisions match those filters.
Source: CMS HCPCS application summaries, Third Quarter 2025 coding cycle (PDF) . Data current as of October 7, 2026.
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