HCPCS Code Applications and Approvals
Updated quarterly · CMS Level II HCPCSCodes take effect Jan 1, 2027
45 coding decisions take effect starting January 1, 2027
BuyandBill.com publishes a summary of the Centers for Medicare and Medicaid Services (CMS) Level II HCPCS coding decisions for the most recent quarter. Level II HCPCS applications are submitted to CMS two quarters in advance.
The decision for an application submitted in quarter two is released in quarter three and becomes effective in quarter four. 9 of this quarter's decisions wait until April 1, 2027.
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 2027
| HCPCS | Drug & Descriptor | Company | Code Change | Action | Effective |
|---|---|---|---|---|---|
| A9696 | AMBELVIST Injection, gadoquatrane, 0.1 ml | Bayer HealthCare LLC Intravenous | — | Establish | |
| C9311 | WAINUA Injection, eplontersen, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) | AstraZeneca Pharmaceuticals LP. Subcutaneous | Replaced byJ0226 | Discontinue | |
| C9312 | EVDI 505(b)(2) Injection, trabectedin (apotex), not therapeutically equivalent to J9362, 0.01 mg | Apotex, Corp. Intravenous | Replaced byJ9363 | Discontinue | |
| C9313 | DECNUPAZ Injection, pivekimab sunirine-pvzy, 0.01 mg | AbbVie Intravenous | Replaced byJ9279 | Discontinue | |
| J0226 | WAINUA Injection, eplontersen, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) | AstraZeneca Pharmaceuticals LP. Subcutaneous | ReplacesC9311 | Establish | |
| J0332 | Rocuronium Bromide 505(b)(2) Injection, rocuronium bromide, 0.1 mg | Fresenius Kabi USA Intravenous | — | Establish | |
| J0491 | Anifrolumab-Fnia Injection, anifrolumab-fnia, intravenous, 1 mg | — | — | Revise | |
| J0670 | Mepivacaine Hydrochloride Injection, mepivacaine hydrochloride, per 10 ml | — | Replaced byJ0671 | Discontinue | |
| J0671 | Mepivacaine Hydrochloride Injection, mepivacaine hydrochloride, 1 mg | — | ReplacesJ0670 | Establish | |
| J0871 | Daptomycin 505(b)(2) Injection, daptomycin (par health), not therapeutically equivalent to j0878, 1 mg | MAIA Pharmaceuticals, Inc. Intravenous | — | Revise | |
| J1433 | NAVITRUX 505(b)(2) Injection, fosaprepitant (avyxa), 1 mg | AVYXA Pharma, LLC Intravenous | — | Establish | |
| J2183 | Meropenem Injection, meropenem, not therapeutically equivalent to j2185, 100 mg | Mylan Institutional LLC, a Viatris company Intravenous | — | Revise | |
| J2544 | Piperacillin Sodium/Tazobactam Sodium (B. Braun) Injection, piperacillin sodium/tazobactam sodium (b. braun), 1 gram/0.125 grams (1.125 grams) | — | — | Establish | |
| J3242 | Lumvoa Injection, veligrotug-vvze, 1 mg | Viridian Therapeutics Intravenous | — | Establish | |
| J3388 | KRESLADI Injection, marnetegragene autotemcel, per treatment | Rocket Pharmaceuticals, Inc. Intravenous | — | Establish | |
| J3407 | OTARMENI Injection, lunsotogene parvec-cwha, per treatment | Regeneron Pharmaceuticals, Inc. Intracochlear | — | Establish | |
| J7030 | Normal Saline Solution Infusion, normal saline solution, 1000 cc | — | Replaced byJ7050 | Discontinue | |
| J7040 | Normal Saline Solution Infusion, normal saline solution, sterile (500 ml = 1 unit) | — | Replaced byJ7050 | Discontinue | |
| J7050 | Normal Saline Solution Infusion, normal saline solution, 250 ml | — | ReplacesJ7030ReplacesJ7040 | Revise | |
| J7060 | Dextrose 5% Injection 5% dextrose/water (500 ml = 1 unit) | — Intravenous | Replaced byJ7065 | Discontinue | |
| J7065 | Dextrose 5% Injection Infusion, dextrose 5% in water solution, 250 ml | — Intravenous | ReplacesJ7060ReplacesJ7070 | Establish | |
| J7070 | Dextrose 5% Injection Infusion, d5w, 1000 cc | — Intravenous | Replaced byJ7065 | Discontinue | |
| J7293 | ZYCUBO Injection, copper histidinate, 0.01 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) | — Subcutaneous | — | Establish | |
| J7518 | Mycophenolic Acid Mycophenolic acid, oral, 180 mg | — | — | Discontinue | |
| J7532 | Mycophenolate Sodium Mycophenolate sodium, oral, 5 mg | — | — | Establish | |
| J7604 | Acetylcysteine Inhalation Solution Acetylcysteine, inhalation solution, compounded product, administered through dme, unit dose form, per gram | — Inhalation | Replaced byJ7623 | Discontinue | |
| J7608 | Acetylcysteine Inhalation Solution Acetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per gram | — Inhalation | Replaced byJ7646 | Discontinue | |
| J7623 | Acetylcysteine Inhalation Solution Acetylcysteine, inhalation solution, compounded product, administered through dme, unit dose form, 5 mg | — Inhalation | ReplacesJ7604 | Establish | |
| J7646 | Acetylcysteine Inhalation Solution Acetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, 5 mg | — Inhalation | ReplacesJ7608 | Establish | |
| J8503 | Aprepitant Injectable Emulsion 505(b)(2) Injection, aprepitant (sandoz), 1 mg | Sandoz Intravenous | — | Establish | |
| J9245 | Melphalan Hydrochloride Injection, melphalan hydrochloride, not otherwise specified, 50 mg | — | Replaced byJ9251 | Discontinue | |
| J9251 | Melphalan Hydrochloride Injection, melphalan hydrochloride, not otherwise specified, 1 mg | — | ReplacesJ9245 | Establish | |
| J9279 | DECNUPAZ Injection, pivekimab sunirine-pvzy, 0.01 mg | AbbVie Intravenous | ReplacesC9313 | Establish | |
| J9363 | EVDI 505(b)(2) Injection, trabectedin (apotex), not therapeutically equivalent to J9362, 0.01 mg | Apotex, Corp. Intravenous | ReplacesC9312 | Establish | |
| J9393 | CLIGAVYX 505(b)(2) Injection, fulvestrant (teva), not therapeutically equivalent to j9395, 25 mg | Avyxa Pharma, LLC Intramuscular | Replaced byJ9396 | Discontinue | |
| J9394 | Fulvestrant (Fresenius Kabi) Injection, fulvestrant (fresenius kabi) not therapeutically equivalent to j9395, 25 mg | — | Replaced byJ9397 | Discontinue | |
| J9395 | Fulvestrant Injection, fulvestrant, 25 mg | — | Replaced byJ9397 | Discontinue | |
| J9396 | CLIGAVYX 505(b)(2) Injection, fulvestrant (avyxa), 1 mg | Avyxa Pharma, LLC Intramuscular | ReplacesJ9393 | Establish | |
| J9397 | Fulvestrant Injection, fulvestrant, 1 mg | — | ReplacesJ9394ReplacesJ9395 | Establish | |
| Q0238 | TYENNE Injection, tocilizumab-aazg, for hospitalized adults and pediatric patients (2 years of age and older) 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 | Fresenius-Kabi Intravenous | — | Revise | |
| Q5156 | AVTOZMA Intravenous Biosimilar Injection, tocilizumab-anoh, biosimilar, intravenous, 1 mg | Celltrion USA, Inc. Intravenous | — | Revise | |
| Q5174 | Avzivi Biosimilar Injection, bevacizumab-tnjn, biosimilar, 10 mg | Sandoz Intravenous | — | Establish | |
| Q5175 | IMMGOLIS/IMMGOLIS INTRI Biosimilar Injection, golimumab-sldi, biosimilar, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) | Accord Biopharma Inc. Subcutaneous/Intravenous | — | Establish | |
| Q5176 | ENNUMO Biosimilar Injection, pegfilgrastim-pccg, biosimilar, 0.5 mg | Accord Biopharma Inc. Subcutaneous | — | Establish | |
| Q5177 | Ranluspec Biosimilar Injection, ranibizumab-hkdz, biosimilar, 0.1 mg | Lupin Pharmaceuticals, Inc. Intravitreal | — | Establish |
No coding decisions match those filters.
Source: CMS HCPCS application summaries, Third Quarter 2026 coding cycle (PDF) . Data current as of October 7, 2026.
Previous Quarters
Decisions per quarter since July 2022 · select a bar to open that quarter
The Pathway
How the HCPCS Level II Application Process Works
Understanding this pathway is crucial to the successful launch of a HCPCS-coded drug.
Submission Quarter
-
Application Submission
A company submits a request for a new or revised code, with clinical and cost justification.
-
Preliminary Internal Review
CMS confirms the application is complete and meets the basic criteria for consideration.
-
Public Meetings
CMS holds open meetings where the applicant, stakeholders, and the public give input.
Decision
-
Primary Decision Factors
CMS weighs clinical value, how distinct the product is, Medicare relevance, and cost.
Publication
-
Final Decision
CMS establishes a new code, revises an existing one, or denies the request with reasons.
-
Notification
Applicants are notified and the decisions are published publicly on the CMS website.
Effective Quarter
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Implementation
Approved codes take effect on the date CMS specifies, so providers can bill accurately.
Ongoing
-
Annual Review
CMS keeps reviewing and updating codes as medical practice and technology evolve.
Frequently asked questions
When do new HCPCS codes take effect?
HCPCS coding decisions take effect on the first day of the quarter. Level II HCPCS applications (like the ones on this page) are submitted to CMS two quarters in advance. A decision on an application submitted in quarter two is released in quarter three and becomes effective in quarter four. The codes on this page take effect January 1, 2027.
How often is this HCPCS approvals list updated?
BuyandBill.com updates this summary each quarter to reflect the most recent CMS Level II HCPCS coding decisions. Typically, HCPCS coding decisions are published 2 to 2½ months ahead of their effective dates. For example, HCPCS coding decisions for July 1st would be released in late April.
What's the difference between Level I and Level II HCPCS?
Level I HCPCS is the CPT code set, maintained by the American Medical Association, used to report medical procedures and services. Level II HCPCS is a separate alphanumeric code set, maintained by CMS, for products and services not covered by CPT, such as drugs, biologicals, and supplies. The drug codes on this page are Level II HCPCS.
What is the difference between 'Establish Code' and 'Revise Code'?
Establish Code means CMS created a new HCPCS code for the product. Revise Code means CMS updated an existing HCPCS code, which can include changing its HCPCS description or dosage.
What is a 505(b)(2) drug?
The 505(b)(2) pathway is an abbreviated FDA approval process that sits between a full New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA, the generic pathway). Because the result is a distinct product, a 505(b)(2) drug typically receives its own unique HCPCS J-code. The table notes whether each product used this pathway.
Related resources
- J-code drug list Search HCPCS J-codes for office-administered drugs.
- Q-code drug list Search HCPCS Q-codes for biosimilars, the equivalent of J-codes.
- Biosimilars How biosimilars differ from generics, and how they are coded.
- 505(b)(2) drugs How the FDA pathway affects coding and pricing.
- Medically Unlikely Edits The maximum billable units per day for each HCPCS drug code.
