HCPCS Code Applications and Approvals

Updated quarterly
Effective date
Last updated
Source
CMS HCPCS

Overview

BuyandBill.com publishes a general 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.

This means the decision for an application submitted in quarter two is released in quarter three and becomes effective in quarter four. The table below covers the code applications and approvals for the upcoming quarter.

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.
505(b)(2)
Whether the product was approved under the FDA 505(b)(2) pathway, which affects ASP reporting and coding treatment.
Effective Date
First date of service on which the code may be billed. Codes effective before this quarter reflect retroactive establishment.
Drug Name HCPCS HCPCS Code Descriptor Company ROA 505(b)(2) Action Effective Date
500 Ml = 1 Unit J7040 Infusion, normal saline solution, sterile (500 ml = 1 unit) — Discontinue
AMBELVIST A9696 Injection, gadoquatrane, 0.1 ml Bayer HealthCare LLC Intravenous — Establish
Anifrolumab-Fnia J0491 Injection, anifrolumab-fnia, intravenous, 1 mg — Revise
Aprepitant Injectable Emulsion J8503 Injection, aprepitant (sandoz), 1 mg Sandoz Intravenous Yes Establish
Avzivi Q5174 Injection, bevacizumab-tnjn, biosimilar, 10 mg Sandoz Intravenous — Establish
B. Braun J2544 Injection, piperacillin sodium/tazobactam sodium (b. braun), 1 gram/0.125 grams (1.125 grams) — Establish
CLIGAVYX J9396 Injection, fulvestrant (avyxa), 1 mg Avyxa Pharma, LLC Intramuscular Yes Establish
CLIGAVYX J9393 Injection, fulvestrant (teva), not therapeutically equivalent to j9395, 25 mg Avyxa Pharma, LLC Intramuscular Yes Discontinue
DECNUPAZ J9279 Injection, pivekimab sunirine-pvzy, 0.01 mg AbbVie Intravenous — Establish
DECNUPAZ C9313 Injection, pivekimab sunirine-pvzy, 0.01 mg AbbVie Intravenous — Discontinue
ENNUMO Q5176 Injection, pegfilgrastim-pccg, biosimilar, 0.5 mg Accord Biopharma Inc. Subcutaneous — Establish
EVDI J9363 Injection, trabectedin (apotex), not therapeutically equivalent to J9362, 0.01 mg Apotex, Corp. Intravenous Yes Establish
EVDI C9312 Injection, trabectedin (apotex), not therapeutically equivalent to J9362, 0.01 mg Apotex, Corp. Intravenous Yes Discontinue
Fresenius Kabi J9394 Injection, fulvestrant (fresenius kabi) not therapeutically equivalent to j9395, 25 mg — Discontinue
Fulvestrant J9397 Injection, fulvestrant, 1 mg — Establish
Fulvestrant J9395 Injection, fulvestrant, 25 mg — Discontinue
IMMGOLIS/IMMGOLIS INTRI Q5175 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
KRESLADI J3388 Injection, marnetegragene autotemcel, per treatment Rocket Pharmaceuticals, Inc. Intravenous — Establish
Lumvoa J3242 Injection, veligrotug-vvze, 1 mg Viridian Therapeutics Intravenous — Establish
Melphalan Hydrochloride J9251 Injection, melphalan hydrochloride, not otherwise specified, 1 mg — Establish
Melphalan Hydrochloride J9245 Injection, melphalan hydrochloride, not otherwise specified, 50 mg — Discontinue
Mycophenolate Sodium J7532 Mycophenolate sodium, oral, 5 mg — Establish
Mycophenolic Acid J7518 Mycophenolic acid, oral, 180 mg — Discontinue
NAVITRUX J1433 Injection, fosaprepitant (avyxa), 1 mg AVYXA Pharma, LLC Intravenous Yes Establish
Normal Saline Solution J7050 Infusion, normal saline solution, 250 ml — Revise
Normal Saline Solution J7030 Infusion, normal saline solution, 1000 cc — Discontinue
OTARMENI J3407 Injection, lunsotogene parvec-cwha, per treatment Regeneron Pharmaceuticals, Inc. — Establish
Ranluspec Q5177 Injection, ranibizumab-hkdz, biosimilar, 0.1 mg Lupin Pharmaceuticals, Inc. Intravitreal — Establish
Rocuronium Bromide J0332 Injection, rocuronium bromide, 0.1 mg Fresenius Kabi USA Intravenous Yes Establish
TYENNE Q0238 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
WAINUA J7060 AstraZeneca Pharmaceuticals LP. Subcutaneous — Discontinue
WAINUA J7065 Infusion, dextrose 5% in water solution, 250 ml AstraZeneca Pharmaceuticals LP. Subcutaneous — Establish
WAINUA J7070 Infusion, d5w, 1000 cc AstraZeneca Pharmaceuticals LP. Subcutaneous — Discontinue
WAINUA J7293 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) AstraZeneca Pharmaceuticals LP. Subcutaneous — Establish
WAINUA J7608 Acetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per gram AstraZeneca Pharmaceuticals LP. Subcutaneous — Discontinue
WAINUA J7646 Acetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, 5 mg AstraZeneca Pharmaceuticals LP. Subcutaneous — Establish
WAINUA J7623 Acetylcysteine, inhalation solution, compounded product, administered through dme, unit dose form, 5 mg AstraZeneca Pharmaceuticals LP. Subcutaneous — Establish
WAINUA J7604 Acetylcysteine, inhalation solution, compounded product, administered through dme, unit dose form, per gram AstraZeneca Pharmaceuticals LP. Subcutaneous — Discontinue
WAINUA J0671 Injection, mepivacaine hydrochloride, 1 mg AstraZeneca Pharmaceuticals LP. Subcutaneous — Establish
WAINUA J0670 Injection, mepivacaine hydrochloride, per 10 ml AstraZeneca Pharmaceuticals LP. Subcutaneous — Discontinue
WAINUA C9311 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 — Discontinue
WAINUA J0226 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 — Establish

Source: CMS Level II HCPCS quarterly coding decisions. Data current as of October 2, 2026.

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

  1. Application Submission

    A company submits a request for a new or revised code, with clinical and cost justification.

  2. Preliminary Internal Review

    CMS confirms the application is complete and meets the basic criteria for consideration.

  3. Public Meetings

    CMS holds open meetings where the applicant, stakeholders, and the public give input.

Decision

  1. Primary Decision Factors

    CMS weighs clinical value, how distinct the product is, Medicare relevance, and cost.

Publication

  1. Final Decision

    CMS establishes a new code, revises an existing one, or denies the request with reasons.

  2. Notification

    Applicants are notified and the decisions are published publicly on the CMS website.

Effective Quarter

  1. Implementation

    Approved codes take effect on the date CMS specifies, so providers can bill accurately.

Ongoing

  1. 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.

Learn more about 505(b)(2) drugs →

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