HCPCS Code Applications and Approvals: July 2026

Quarterly archive · CMS Level II HCPCS

First Quarter 2026 coding cycle · Effective · Source: CMS application summaries (PDF) ↗

27 coding decisions from the First Quarter 2026 CMS cycle

These are the Centers for Medicare and Medicaid Services (CMS) Level II HCPCS drug coding decisions from the First Quarter 2026 coding cycle, which took effect July 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.
HCPCS Drug & Descriptor Company Code Change Action Effective
A9574
FERABRIGHT

Injection, ferumoxytol, 1 mg

Azurity Pharmaceuticals Inc. Intravenous — Establish
C9309
ITVISMA

Injection, onasemnogene abeparvovec-brve, per treatment

Novartis Pharmaceuticals Corporation Intrathecal Replaced byJ3405 Discontinue
J0528
CONTEPO 505(b)(2)

Injection, fosfomycin disodium, 20 mg

Meitheal Pharmaceuticals, Inc. Intravenous — Establish
J1289
YARTEMLEA

Injection, narsoplimab-wuug, 1 mg

Omeros Corporation Intravenous — Establish
J1553
YIMMUGO

Injection, immune globulin (yimmugo), 100 mg

Kedrion Biopharma, Inc. Intravenous — Establish
J1569
GAMMAGARD LIQUID ERC

Injection, immune globulin, (gammagard liquid/gammagard liquid erc), 500 mg

Takeda Pharmaceuticals Intravenous/Subcutaneous — Revise
J1577
QIVIGY

Injection, immune globulin (qivigy), 100 mg

Kedrion Biopharma, Inc. Intravenous — Establish
J2361
Exdensur

Injection, depemokimab-ulaa, 1 mg

GSK Subcutaneous — Establish
J2374
IOPIDINE

Apraclonidine hydrochloride ophthalmic, 1% solution, 0.1 ml

Harrow Inc. Ophthalmic — Establish
J2787
Riboflavin 5'-Phosphate (Photrexa Viscous/Photrexa) 505(b)(2)

Riboflavin 5'-phosphate, ophthalmic solution (photrexa viscous/photrexa), up to 3 ml

Glaukos Ophthalmic — Revise
J2789
Epioxa HD/Epioxa 505(b)(2)

Riboflavin 5'-phosphate, ophthalmic solution (epioxa hd/epioxa), up to 2 ml

Glaukos Ophthalmic — Establish
J3375
TYZAVAN 505(b)(2)

Injection, vancomycin hydrochloride (tyzavan), not therapeutically equivalent to j3373, 10 mg

Hikma Pharmaceuticals USA Inc. Intravenous — Revise
J3386
WASKYRA

Injection, etuvetidigene autotemcel, per treatment

Fondazione Telethon Intravenous — Establish
J3405
ITVISMA

Injection, onasemnogene abeparvovec-brve, per treatment

Novartis Pharmaceuticals Corporation Intrathecal ReplacesC9309 Establish
J7176
FESILTY

Injection, human fibrinogen - chmt (fesilty), 1 mg

Grifols Therapeutics, LLC Intravenous — Establish
J9053
Blenrep

Injection, belantamab mafodotin-blmf, 0.1 mg

GSK Intravenous — Establish
J9062
RYBREVANT FASPRO

Injection, amivantamab 5 mg and hyaluronidase-lpuj

Johnson & Johnson Health Care Systems Inc. Subcutaneous — Establish
J9232
Docetaxel (Hospira) 505(b)(2)

Injection, docetaxel (hospira), not therapeutically equivalent to j9171, 1 mg

Pfizer/Hospira Intravenous — Establish
Q0234
Tofidence (COVID-19)

Injection, tocilizumab-bavi, 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 only, 1 mg

Sandoz Inc. Intravenous — Establish
Q5164
STARJEMZA Biosimilar

Injection, ustekinumab-hmny (starjemza), biosimilar, 1 mg

Hikma Pharmaceuticals Subcutaneous/Intravenous — Establish
Q5165
Oziltus Biosimilar

Injection, denosumab-mobz (oziltus), biosimilar, 1 mg

Amneal Pharmaceuticals Subcutaneous — Establish
Q5166
OSVYRTI/JUBEREQ Biosimilar

Injection, denosumab-desu (osvyrti/jubereq), biosimilar, 1 mg

Accord Biopharma Subcutaneous — Establish
Q5167
Enoby/Xtrenbo Biosimilar

Injection, denosumab-qbde (enoby/xtrenbo), biosimilar, 1 mg

Hikma Pharmaceuticals USA Inc. Subcutaneous — Establish
Q5168
NUFYMCO Biosimilar

Injection, ranibizumab-leyk (nufymco), biosimilar, 0.1 mg

Bioeq AG Intravitreal — Establish
Q5169
Armlupeg Biosimilar

Injection, pegfilgrastim-unne (armlupeg), biosimilar, 0.5 mg

Valorum Biologics LLC Subcutaneous — Establish
Q5170
EYDENZELT Biosimilar

Injection, aflibercept-boav (eydenzelt), biosimilar, 1 mg

Celltrion USA, Inc. Intravitreal — Establish
Q5171
Boncresa Biosimilar

Injection, denosumab-mobz (boncresa), biosimilar, 1 mg

Amneal Pharmaceuticals Subcutaneous — Establish

Source: CMS HCPCS application summaries, First Quarter 2026 coding cycle (PDF) . Data current as of October 7, 2026.

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