Heads up: this issue is from September 30, 2025. Because it covers time-sensitive coding and regulatory topics, some details may have changed since. See the latest issues for current guidance.
As you are aware, the Hospital Outpatient Fee Schedule changes for a subset of drugs every quarter. For drugs administered on or after October 1, 2025, the changes to the drug listed in Transmittal 13425, Change Request 14223, are provided below.
New COVID Antibody Products and Antibodies Codes
Effective August 27, 2025, CMS is retroactively changing the code’s status indicator from E1 (Not Paid) to L (Not paid under OPPS. Paid at reasonable code; not subject to deductible or coinsurance) in the October 2025 Integrated Outpatient Code Editor (I/OCE). M0237-M0238 are status indicator S, meaning not subject to multi-procedure reduction, effective 1/24/25.
- Q0237 — 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
- M0237 — Intravenous infusion, 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, includes infusion and post administration monitoring, first dose
- M0238 — Intravenous infusion, 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, includes infusion and post administration monitoring, second dose
CMS is also establishing a not otherwise classified COVID-19 monoclonal antibody product HCPCS
Level II code and associated administrative codes for any newly FDA-approved products that we
haven’t been assigned to a unique HCPCS Level II code while the Emergency Use Authorization
The declaration under section 564 of the Federal Food, Drug, and Cosmetic Act remains in effect.
- Q0235 — 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
- M0235 — Intravenous infusion, 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, includes infusion and post administration monitoring, not otherwise classified, first dose
- M0236 — Intravenous infusion, 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, including infusion and post administration monitoring, not otherwise classified, second dose
Effective October 1, 2025, in the October 2025 I/OCE update, CMS is assigning:
- HCPCS code Q0235 to status indicator L (Status for COVID therapies)
- HCPCS codes M0235 and M0236 to status indicator S (Not subject to multiple procedure reductions) and APC 1506
New HCPCS Codes Gaining Pass-Through Status
- A9616 Gallium ga-68 gozetotide (gozellix), diagnostic, 1 millicurie
- C9305 Injection, nipocalimab-aahu, 3 mg
- C9306 Injection, telisotuzumab vedotin-tllv, 1 mg
- J0458 Injection, aztreonam/avibactam, 7.5 mg/2.5 mg (10 mg)
- J0681 Injection, ceftobiprole medocaril sodium, 3 mg
- J3403 Revakinagene taroretcel-lwey, per implant
- J7174 Injection, fitusiran, 0.04 mg
Existing HCPCS Codes Gaining Pass-Through Status
- Q5151 Injection, eculizumab-aagh (epysqli), biosimilar, 2 mg
- Q9998 Injection, ustekinumab-aekn (selarsdi), biosimilar, 1 mg
- Q9999 Injection, ustekinumab-aauz (otulfi), biosimilar, 1 mg
HCPCS Codes Losing Pass-Through Status
- A9602 Fluorodopa f-18, diagnostic, per millicurie
- A9607 Lutetium lu 177 vipivotide tetraxetan, , 1millicurie
- C9101 Injection, oliceridine, 0.1 mg
- J1952 Leuprolide injectable, camcevi, 1 mg
- J9298 Injection, nivolumab and relatlimab-rmbw, 3 mg/1 mg
- Q5126 Injection, bevacizumab-maly, biosimilar, (alymsys), 10 mg
HCPCS Code for Drug, Biological, and Radiopharmaceutical Reinstated Effective October 1, 2025
- J0570 Buprenorphine implant, 74.2 mg
Deleted HCPCS Codes
- J2150 Injection, mannitol, 25% in 50 ml D N/A
- J2503 Injection, pegaptanib sodium, 0.3 mg
Code Status Change as of July 7, 2025 (10/1 status in parentheses)
- J0207 Injection, amifostine, 500 mg (E1, Not Paid By Medicare)
- J0210 Injection, methyldopate hcl, up to 250 mg (E1)
- J0364 Injection, apomorphine hydrochloride, 1 mg (E1)
- J0520 Injection, bethanechol chloride, myotonachol or urecholine, up to 5 mg (E1)
- J0567 Injection, cerliponase alfa, 1 mg (K, Paid Separately, Non-Passthrough)
- J0593 Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug is administered under direct supervision of a physician, not for use when drug is self-administered) (K)
- J0599 Injection, c-1 esterase inhibitor (human), (Haegarda), 10 units (K)
- J0889 Daprodustat, oral, 1 mg, (for esrd on dialysis) (E1)
- J0945 Injection, brompheniramine maleate, per 10 mg (E1)
- J1180 Injection, dyphylline, up to 500 mg (E1)
- J1324 Injection, enfuvirtide, 1 mg (E1)
- J1414 Injection, fidanacogene elaparvovec-dzkt, per therapeutic dose (E1)
- J1426 Injection, casimersen, 10 mg (K)
- J1428 Injection, eteplirsen, 10 mg (K)
- J1435 Injection, estrone, per 1 mg (E1)
- J1600 Injection, gold sodium thiomalate, up to mg (E1)
- J1730 Injection, diazoxide, up to 300 mg (E1)
- J1749 Injection, iloprost, 0.1 mcg (N)
- J1814 Insulin (lyumjev), per 5 units (N)
- J1830 Injection interferon beta-1b, 0.25 mg (code may be used for Medicare when the drug is administered under the directsupervision of a physician, not for use when the drug is self-administered) (E1)
- J1835 Injection, itraconazole, 50 mg (E1)
- J1960 Injection, levorphanol tartrate, up to 2 mg (E1)
- J2062 Loxapine for inhalation, 1 mg (K)
- J2402 Injection, chloroprocaine hydrochloride (clorotekal), per 1 mg (N)
- J2460 Injection, oxytetracycline hcl, up to 50 mg (E1)
- J2650 Injection, prednisolone acetate, up to 1 ml (E1)
- J2670 Injection, tolazoline hcl, up to 25 mg (E1)
- J2725 Injection, protirelin, per 250 mcg (E1)
- J2793 Injection, rilonacept, 1 mg (E1)
- J2810 Injection, theophylline, per 40 mg (E1)
- J3397 Injection, vestronidase alfa-vjbk, 1 mg (K)
- J8565 Gefitinib, oral, 250 mg (E1)
- J8600 Melphalan; oral, 2 mg (E1)
- J9118 Injection, calaspargase pegol-mknl, 10 units (K)
- J9213 Injection, interferon, alfa-2a, recombinant, 3 million units (E1)
- J9215 Injection, interferon, alfa-n3, (human leukocyte derived), 250,000 iu (E1)
- J9216 Injection, interferon, gamma 1-b, 3 million units (E1)
- J9219 leuprolide acetate implant, 65 mg (E1)
- J9285 Injection, olaratumab, 10 mg (E1)
- J9322 Injection, pemetrexed (bluepoint), not therapeutically equivalent to j9305, 10 mg (K)
- J9376 Injection, pozelimab-bbfg, 1 mg (K)
- Q0173 Trimethobenzamide hydrochloride, 250 mg, oral, fda
- approved prescription anti-emetic, for use as a complete Therapeutic substitute for an IV anti-emetic at the time of chemotherapy treatment, not to exceed a 48-hour (N)
- Q0515 Injection, sermorelin acetate, 1 microgram (E1)
- Q5138 Injection, ustekinumab-auub (wezlana), biosimilar, intravenous, 1 mg (K)
Code Status Change Retroactive to JULY 1, 2025
- 90382 Respiratory syncytial virus, monoclonal antibody, seasonal dose, 0.7 mL, for intramuscular use (M)
- J0283 Injection, amiodarone hydrochloride (nexterone), 30 mg (N)
- J0874 Injection, daptomycin (baxter), not therapeutically equivalent to j0878, 1 mg (N)
- J2246 Injection, micafungin in sodium (baxter), not therapeutically equivalent to j2248, 1 mg (N)
- J9076 Injection, cyclophosphamide (baxter), 5 mg (K)
- Q9997 Injection, ustekinumab-ttwe (pyzchiva), intravenous, 1 mg (K)
Code Descriptor Substantial Changes as of October 1, 2025
- J1961 Injection, lenacapavir, 1 mg Injection, lenacapavir (only for use as hiv treatment), 1 mg
- J9072 Injection, cyclophosphamide (avyxa), 5 mg
That's all for this quarter. For more information about non-drug changes, check the transmittal.
