HCPCS Code Applications and Approvals: July 2025
Quarterly archive · CMS Level II HCPCS59 coding decisions from the First Quarter 2025 CMS cycle
These are the Centers for Medicare and Medicaid Services (CMS) Level II HCPCS drug coding decisions from the First Quarter 2025 coding cycle, which took effect July 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.
July 2025
| HCPCS | Drug & Descriptor | Company | Code Change | Action | Effective |
|---|---|---|---|---|---|
| C9300 | BLUDIGO 505(b)(2) Injection, indigotindisulfonate sodium, 1 mg | Provepharm, Inc. | Replaced byJ9220 | Discontinue | |
| C9301 | AUCATZYL Obecabtagene autoleucel, up to 400 million cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose | Autolus Therapeutics plc Intravenous | Replaced byQ2058 | Discontinue | |
| C9302 | ZIIHERA | Jazz Pharmaceuticals Intravenous | Replaced byJ9276 | Discontinue | |
| C9303 | VYLOY Injection, zolbetuximab-clzb, 1 mg | Astellas Intravenous | Replaced byJ1326 | Discontinue | |
| C9304 | HYMPAVZI Injection, marstacimab-hncq, 0.5 mg | Pfizer Inc. Subcutaneous | Replaced byJ7172 | Discontinue | |
| J0165 | Epinephrine Injection, epinephrine, not otherwise specified, 0.1 mg | — | — | Establish | |
| J0166 | Epinephrine (Bpi) 505(b)(2) Injection, epinephrine (bpi), not therapeutically equivalent to j0165, 0.1 mg | — | — | Establish | |
| J0167 | Epinephrine (Hospira) 505(b)(2) Injection, epinephrine (hospira), not therapeutically equivalent to j0165, 0.1 mg | — | — | Establish | |
| J0168 | Epinephrine (International Medication Systems) 505(b)(2) Injection, epinephrine (international medication systems), not therapeutically equivalent to j0165, 0.1 mg | — | — | Establish | |
| J0169 | Epinephrine (Adrenalin) 505(b)(2) Injection, epinephrine (adrenalin), not therapeutically equivalent to j0165, 0.1 mg | — | — | Establish | |
| J0171 | Adrenalin Injection, adrenalin, epinephrine, 0.1 mg | — | — | Discontinue | |
| J0173 | Epinephrine (Belcher) Injection, epinephrine (belcher), not therapeutically equivalent to j0171, 0.1 mg | — | — | Discontinue | |
| J0616 | Metoprolol Tartrate Injection, metoprolol tartrate, 1 mg | — | — | Establish | |
| J0618 | Calcium Chloride Injection, calcium chloride, 2 mg | — | — | Establish | |
| J1163 | Diltiazem Hydrochloride Injection, diltiazem hydrochloride, 0.5 mg | — | — | Establish | |
| J1326 | VYLOY Injection, zolbetuximab-clzb, 2 mg | Astellas Intravenous | ReplacesC9303 | Establish | |
| J1954 | Lutrate Depot 505(b)(2) Injection, leuprolide acetate for depot suspension (lutrate depot), 7.5 mg | Cipla Pharmaceuticals (Cipla) Intramuscular | — | Revise | |
| J2310 | Naloxone Hydrochloride Injection, naloxone hydrochloride, per 1 mg | — | — | Discontinue | |
| J2311 | Naloxone Hydrochloride (Zimhi) Injection, naloxone hydrochloride (zimhi), 1 mg | — | Replaced byJ2313 | Discontinue | |
| J2312 | Naloxone Hydrochloride 505(b)(2) Injection, naloxone hydrochloride, not otherwise specified, 0.01 mg | — | — | Establish | |
| J2313 | Naloxone Hydrochloride (Zimhi) 505(b)(2) Injection, naloxone hydrochloride (zimhi), 0.01 mg | — | ReplacesJ2311 | Establish | |
| J3370 | Vancomycin Hcl Injection, vancomycin hcl, 500 mg | — | — | Discontinue | |
| J3371 | Vancomycin Hydrocholoride for Injection 505(b)(2) Injection, vancomycin hcl (mylan) not therapeutically equivalent to j3370, 500 mg | Mylan Pharmaceuticals Inc. | Replaced byJ3374 | Discontinue | |
| J3372 | Vancomycin Hcl (Xellia) Injection, vancomycin hcl (xellia), not therapeutically equivalent to j3370, 500 mg | — | — | Discontinue | |
| J3373 | Vancomycin Hydrochloride Injection, vancomycin hydrochloride, 10 mg | — | — | Establish | |
| J3374 | Vancomycin Hydrocholoride for Injection 505(b)(2) Injection, vancomycin hydrochloride (mylan) not therapeutically equivalent to j3373, 10 mg | Mylan Pharmaceuticals Inc. | ReplacesJ3371 | Establish | |
| J3375 | Vancomycin Hydrochloride (Xellia) Injection, vancomycin hydrochloride (xellia), not therapeutically equivalent to j3373, 10 mg | — | — | Establish | |
| J3391 | Lenmeldy Injection, atidarsagene autotemcel, per treatment | Orchard Therapeutics | — | Establish | |
| J7172 | HYMPAVZI Injection, marstacimab-hncq, 0.5 mg | Pfizer Inc. Subcutaneous | ReplacesC9304 | Establish | |
| J7356 | VYALEV Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg | AbbVie Subcutaneous | — | Establish | |
| J9174 | BEIZRAY 505(b)(2) Injection, docetaxel (beizray), 1 mg | Zhuhai Beihai Biotech Co., Ltd. Intravenous | — | Establish | |
| J9220 | BLUDIGO 505(b)(2) Injection, indigotindisulfonate sodium, 1 mg | Provepharm, Inc. | ReplacesC9300 | Establish | |
| J9275 | UNLOXCYT Injection, cosibelimab-ipdl, 2 mg | Checkpoint Therapeutics, Inc. Intravenous | — | Establish | |
| J9276 | ZIIHERA Injection, zanidatamab-hrii, 2 mg | Jazz Pharmaceuticals Intravenous | ReplacesC9302 | Establish | |
| J9289 | OPDIVO Qvantig Injection, nivolumab, 2 mg and hyaluronidase-nvhy | Bristol Myers Squibb Subcutaneous | — | Establish | |
| J9292 | Pemetrexed Dipotassium 505(b)(2) Injection, pemetrexed dipotassium, 10 mg | — | — | Revise | |
| J9340 | Thiotepa Injection, thiotepa, 15 mg | — | Replaced byJ9342 | Discontinue | |
| J9341 | Tepylute 505(b)(2) Injection, thiotepa (tepylute), 1 mg | Shorla Oncology | — | Establish | |
| J9342 | Thiotepa Injection, thiotepa, not otherwise specified, 1 mg | — | ReplacesJ9340 | Establish | |
| J9382 | BIZENGRI Injection, zenocutuzumab-zbco, 1 mg | Partner Therapeutics, Inc. Intravenous | — | Establish | |
| Q2058 | AUCATZYL Obecabtagene autoleucel, 10 up to 400 million cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per infusion | Autolus Therapeutics plc Intravenous | ReplacesC9301 | Establish | |
| Q4368 | AmchoThick Amchothick, per square centimeter | Cellution Biologics, LLC | — | Establish | |
| Q4369 | AmnioPlast 3 Amnioplast 3, per square centimeter | Cellution Biologics, LLC | — | Establish | |
| Q4370 | AéroGuard Aeroguard, per square centimeter | C5 Biomedical, LLC | — | Establish | |
| Q4371 | NéoGuard Neoguard, per square centimeter | C5 Biomedical, LLC | — | Establish | |
| Q4372 | AmchoPlast EXCEL Amchoplast excel, per square centimeter | Cellution Biologics, LLC | — | Establish | |
| Q4373 | Membrane Wrap-Lite Membrane wrap-lite, per square centimeter | BioLab Holdings, Inc. Topical | — | Establish | |
| Q4375 | duoGRAFT AC Duograft ac, per square centimeter | RegenTX Partners LLC | — | Establish | |
| Q4376 | Duograft AA Duograft aa, per square centimeter | RegenTX Partners | — | Establish | |
| Q4377 | triGRAFT FT Trigraft ft, per square centimeter | RegenTX Partners | — | Establish | |
| Q4378 | Renew FT Matrix Renew ft matrix, per square centimeter | Sequence LifeScience, Inc. | — | Establish | |
| Q4379 | AmnioDefend FT Matrix Amniodefend ft matrix, per square centimeter | Sequence LifeScience, Inc. | — | Establish | |
| Q4380 | AdvoGraft One Advograft one, per square centimeter | RMBB Health | — | Establish | |
| Q4382 | AdvoGraft Membrane Dual Advograft dual, per square centimeter | RMBB Health | — | Establish | |
| Q5098 | IMULDOSA Biosimilar Injection, ustekinumab-srlf (imuldosa), biosimilar, 1 mg | Accord Biopharma | — | Establish | |
| Q5099 | STEQEYMA (Subcutaneous) Biosimilar Injection, ustekinumab-stba (steqeyma), biosimilar, 1 mg | CELLTRION Inc. Subcutaneous | — | Establish | |
| Q5100 | YESINTEK (Subcutaneous) Biosimilar Injection, ustekinumab-kfce (yesintek), biosimilar, 1 mg | Biocon Biologics Intravenous | — | Establish | |
| Q5153 | OPUVIZ Biosimilar Injection, aflibercept-yszy (opuviz), biosimilar, 1 mg | Samsung Bioeps Intravitreal | — | Establish | |
| Q9998 | SELARSDI (Subcutaneous) Biosimilar Injection, ustekinumab-aekn (selarsdi), biosimilar, 1 mg | Teva Pharmaceuticals, Inc. | — | Revise |
No coding decisions match those filters.
Source: CMS HCPCS application summaries, First Quarter 2025 coding cycle (PDF) . Data current as of October 7, 2026.
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