HCPCS Code Applications and Approvals: October 2026

Quarterly archive · CMS Level II HCPCS

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

42 coding decisions took effect October 1, 2026

These are the Centers for Medicare and Medicaid Services (CMS) Level II HCPCS drug coding decisions from the Second Quarter 2026 coding cycle, which took effect October 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
A9595
PYLARIFY TRUVU 505(b)(2)

Piflufolastat f 18 (pylarify), diagnostic, 1 millicurie

Lantheus Medical Imaging, Inc. Intravenous — Revise
A9613
PYLARIFY TRUVU 505(b)(2)

Piflufolastat f 18 (pylarify truvu), diagnostic, 1 millicurie

Lantheus Medical Imaging, Inc. Intravenous — Establish
C9046
GOPRELTO 505(b)(2)

Cocaine hydrochloride nasal solution (goprelto), 1 mg

LXO US Intranasal Replaced byJ0014 Discontinue
C9310
VYKOURA 505(b)(2)

Injection, leucovorin calcium (avyxa), 1 mg

Avyxa Pharma LLC Intramuscular Replaced byJ0644 Discontinue
C9462
Baxdela

Injection, delafloxacin, 1 mg

CorMedix Therapeutics Intravenous/Oral Replaced byJ3268 Discontinue
J0014
GOPRELTO 505(b)(2)

Cocaine hydrochloride nasal solution (goprelto), 1 mg

LXO US Intranasal ReplacesC9046 Establish
J0640
Leucovorin Calcium

Leucovorin calcium, 50 mg

— Replaced byJ0643 Discontinue
J0643
Leucovorin Calcium

Injection, leucovorin calcium, not otherwise specified, 1 mg

— ReplacesJ0640 Establish
J0644
VYKOURA 505(b)(2)

Injection, leucovorin calcium (avyxa), 1 mg

Avyxa Pharma LLC Intramuscular ReplacesC9310 Establish
J0871
Daptomycin (Endo) 505(b)(2)

Injection, daptomycin (endo), not therapeutically equivalent to j0878, 1 mg

Endo Pharmaceuticals Intravenous — Establish
J1757
AVLAYAH

Injection, tividenofusp alfa-eknm, 1 mg

Denali Therapeutics Inc. Intravenous — Establish
J1818
Loargys

Injection, pegzilarginase-nbln, 0.05 mg

Immedica USA Inc. Intravenous — Establish
J1941
Furosemide (Furoscix)

Injection, furosemide (furoscix), 20 mg

— Replaced byJ1947 Discontinue
J1946
Lasix ONYU

Injection, furosemide (lasix onyu), 1 mg

SQ Innovation Inc. Subcutaneous — Establish
J1947
Furosemide (Furoscix) 505(b)(2)

Injection, furosemide (furoscix), 1 mg

— ReplacesJ1941 Establish
J1953
Levetiracetam

Injection, levetiracetam, 10 mg

— Replaced byJ1957 Discontinue
J1957
Levetiracetam

Injection, levetiracetam, 5 mg

— ReplacesJ1953 Establish
J1958
Levetiracetam In Sodium Chloride

Injection, levetiracetam in sodium chloride, 5 mg

— — Establish
J3268
Baxdela

Injection, delafloxacin, 1 mg

CorMedix Therapeutics Intravenous/Oral ReplacesC9462 Establish
J3300
Triamcinolone Acetonide (Triesence)

Injection, triamcinolone acetonide (triesence), preservative free, 1 mg

— — Revise
J3406
OMISIRGE

Injection, omidubicel-onlv, per therapeutic dose

Gamida Cell Intravenous — Establish
J7514
Mycophenolate Mofetil (Myhibbin)

Mycophenolate mofetil (myhibbin), oral suspension, 100 mg

— Replaced byJ7530 Discontinue
J7517
Mycophenolate Mofetil

Mycophenolate mofetil, oral, 250 mg

— Replaced byJ7524 Discontinue
J7519
Mycophenolate Mofetil

Injection, mycophenolate mofetil, 10 mg

— Replaced byJ7526 Discontinue
J7524
Mycophenolate Mofetil

Mycophenolate mofetil, oral, 5 mg

— ReplacesJ7517 Establish
J7526
Mycophenolate Mofetil

Injection, mycophenolate mofetil, 5 mg

— ReplacesJ7519 Establish
J7528
Mycophenolate Mofetil

Mycophenolate mofetil, for suspension, oral, 100 mg

— Replaced byJ7529 Discontinue
J7529
Mycophenolate Mofetil

Mycophenolate mofetil, for suspension, oral, 5 mg

— ReplacesJ7528 Establish
J7530
Mycophenolate Mofetil (Myhibbin) 505(b)(2)

Mycophenolate mofetil (myhibbin), oral suspension, 5 mg

— ReplacesJ7514 Establish
J7531
Prednisolone Sodium Phosphate

Prednisolone sodium phosphate, orally disintegrating tablet, 1 mg

— — Establish
J9033
Bendamustine Hydrochloride

Injection, bendamustine hydrochloride, not otherwise specified, 1 mg

— — Revise
J9066
Bendamustine Hydrochloride Injection 505(b)(2)

Injection, bendamustine hydrochloride (avyxa), 1 mg

AVYXA Pharma, LLC Intravenous — Establish
J9181
Etoposide

Injection, etoposide, 10 mg

— Replaced byJ9187 Discontinue
J9186
AVOPEF 505(b)(2)

Injection, etoposide (avyxa), 1 mg

AVYXA Pharma, LLC Intravenous — Establish
J9187
Etoposide

injection, etoposide, 1 mg

— ReplacesJ9181 Establish
J9190
Fluorouracil

Injection, fluorouracil, 500 mg

— Replaced byJ9192 Discontinue
J9191
FAVLYXA 505(b)(2)

Injection, fluorouracil (avyxa), 10 mg

AVYXA Pharma, LLC Intravenous — Establish
J9192
Fluorouracil

Injection, fluorouracil, 10 mg

— ReplacesJ9190 Establish
J9352
Trabectedin

Injection, trabectedin, 0.1 mg

— Replaced byJ9362 Discontinue
J9362
Trabectedin 505(b)(2)

Injection, trabectedin, 0.01 mg

— ReplacesJ9352 Establish
Q5172
FILKRI Biosimilar

Injection, filgrastim-laha (filkri), biosimilar, 1 microgram

Accord Biopharma Subcutaneous/Intravenous — Establish
Q5173
PONLIMSI Biosimilar

Injection, denosumab-adet (ponlimsi), biosimilar, 1 mg

Teva Pharmaceuticals Subcutaneous — Establish

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

Other Quarters

Decisions per quarter since July 2022 · select a bar to open that quarter