HCPCS Code Applications and Approvals

Effective April 1st, 2024

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 that the decision for a HCPCS application submitted in quarter two is released in quarter three and becomes effective in quarter four. Below, BuyandBill has published a table related to the HCPCS code applications and approvals for the upcoming quarter.

CMS Level II HCPCS Coding Decisions: Effective April 1st, 2024

Drug NameHCPCSHCPCS DescriptorCompanyDrug TypeROA505(b)(2)?TypeEffective Date
BALFAXARJ7165Injection, prothrombin complex
concentrate, human-lans, per i.u. of factor ix activity
OctapharmaAnticoagulant Reversal AgentIntravenousNoAdd Code4/1/2024
POMBILITIJ1203Injection, cipaglucosidase alfa-atga, 5 mgAmicus TherapeuticsEnzyme Replacement TherapyIntravenousNoAdd Code4/1/2024
OPFOLDJ1202Miglustat, oral, 65 mgAmicus TherapeuticsEnzyme Replacement TherapyOralNoAdd Code4/1/2024
VEOPOZJ9376Injection, pozelimab-bbfg, 1 mgRegeneronImmunoglobulinIntravenous and SubcutaneousNoAdd Code4/1/2024
EYLEA® HDJ0177Injection, aflibercept hd, 1 mgRegeneronOpthalmicIntravitrealNoAdd Code4/1/2024
TYRUKOQ5134Injection, natalizumab-sztn (tyruko),
biosimilar, 1 mg
SandozMonoclonal AntibodyIntravenousNoAdd Code4/1/2024
TALVEYJ3055Injection, talquetamab-tgvs, 0.25 mgJohnson & JohnsonOncologySubcutaneousNoAdd Code4/1/2024
APHEXDAJ2277Injection, motixafortide, 0.25 mgBioLineRxOncologySubcutaneousNoAdd Code4/1/2024
TOFIDENCEQ5133Injection, tocilizumab-bavi (tofidence),
biosimilar, 1 mg
BiogenMonoclonal AntibodyIntravenousNoAdd Code4/1/2024
DAXXIFYJ0589Injection, daxibotulinumtoxina-lanm, 1
Revance TherapeuticsNeuromuscularIntramuscularNoAdd Code4/1/2024
ELFREXIOJ1323Injection, elranatamab-bcmm, 1 mgPfizerOncologysubcutaneousNoAdd Code4/1/2024
ENTYVIOJ3380Injection, vedolizumab, intravenous, 1 mgTakedaImmunotherapyIntravenous and SubcutaneousNoRevise Code4/1/2024
HEPZATOJ9248Injection, melphalan (hepzato), 1 mgDelcath SystemsOncologyIntravenousYesAdd Code4/1/2024
RYKINDOJ2801Injection, risperidone (rykindo), 0.5 mgLuye PharmaNeurologyIntramuscularYesAdd Code4/1/2024
FOCINVEZJ1434Injection, fosaprepitant (focinvez), 1 mgAmneal PharmaceuticalsAnti-EmeticIntravenousYesAdd Code4/1/2024
Melphalan Hydrochloride InjectionJ9249Injection, melphalan (apotex), 1 mgApotexOncologyIntravenousYesAdd Code4/1/2024
Cyclophosphamide injectionJ9074Injection, cyclophosphamide (sandoz), 5 mgSandozOncologyIntravenousYesAdd Code4/1/2024
BRIXADIJ0577Injection, buprenorphine extendedrelease
(brixadi), less than or equal to 7 days of therapy
BraeburnOpiod AgonistSubcutaneousYesAdd Code4/1/2024
BRIXADIJ0578Injection, buprenorphine extendedrelease
(brixadi), greater than 7 days of therapy
BraeburnOpiod AgonistSubcutaneousYesAdd Code4/1/2024
BRIXADIJ0576Injection, buprenorphine extended-release
(brixadi), 1 mg
BraeburnOpiod AgonistSubcutaneousYesDiscontinue Code4/1/2024
IZERVAYJ2782Injection, avacincapted pegol, 0.1 mgIveric BioOpthalmicIntravitrealNoAdd Code4/1/2024
YCANTHJ7354Cantharidin for topical administration,
0.7%, single unit dose applicator (3.2 mg)
VerricaAntifungalTopicalNoAdd Code4/1/2024
Sodium ThiosulfateJ0208 Injection, sodium thiosulfate (pedmark), 100 mg PedmarkAntidoteIntravenousYesRevise Code4/1/2024
Sodium ThiosulfateJ0209 Injection, sodium thiosulfate (hope), 100 mg Hope PharmaAntidoteIntravenousYesAdd Code4/1/2024
Calcuium GluconateJ0612 Injection, calcium gluconate, not otherwise specified, 10 mg ?Calcium SaltIntravenousYesRevise Code4/1/2024
Calcuium GluconateJ0613 Injection, calcium gluconate (wg critical care) not therapeutically equivalent to J0612, 10 mg WG Critical CareCalcium SaltIntravenousYesRevise Code4/1/2024
Levothyroxine SodiumJ0650 Injection, levothyroxine sodium, not otherwise specified, 10 mcg ?Hormone Replacement TherapyIntravenousYesAdd Code4/1/2024
Levothyroxine SodiumJ0651 Injection, levothyroxine sodium (fresenius kabi) not therapeutically equivalent to J0650, 10 mcg Fresenius KabiHormone Replacement TherapyIntravenousYesAdd Code4/1/2024
Levothyroxine SodiumJ0652 Injection, levothyroxine sodium (hikma) not therapeutically equivalent to J0650, 10 mcg HikmaHormone Replacement TherapyIntravenousYesAdd Code4/1/2024
Methylprednisolone AcetateJ1010 Injection, methylprednisolone acetate, 1 mg ?CorticosteroidMultipleYesAdd Code4/1/2024
Methylprednisolone AcetateJ1020* Injection, methylprednisolone acetate, 20 mg ?CorticosteroidMultipleYesDiscontinue Code4/1/2024
Methylprednisolone AcetateJ1030* Injection, methylprednisolone acetate, 40 mg ?CorticosteroidMultipleYesDiscontinue Code4/1/2024
Methylprednisolone AcetateJ1040* Injection, methylprednisolone acetate, 80 mg ?CorticosteroidMultipleYesDiscontinue Code4/1/2024
Kanamycin SulfateJ1840* Injection, kanamycin sulfate, up to 500 mg ?AntibioticMultipleYesDiscontinue Code4/1/2024
Kanamycin SulfateJ1850* Injection, kanamycin sulfate, up to 75 mg ?AntibioticMultipleYesDiscontinue Code4/1/2024
HydroxocobalaminJ3424 Injection, hydroxocobalamin, intravenous, 10 grams ?Anti-EnemicMultipleYesAdd Code4/1/2024
Methylprednisolone Sodium SuccinateJ2919 Injection, methylprednisolone sodium succinate, 5 mg ?SteroidMultipleYesAdd Code4/1/2024
Methylprednisolone Sodium SuccinateJ2920* Injection, methylprednisolone sodium succinate, up to 40 mg ?SteroidMultipleYesDiscontinue Code4/1/2024
Methylprednisolone Sodium SuccinateJ2930* Injection, methylprednisolone sodium succinate, up to 125 mg ?SteroidMultipleYesDiscontinue Code4/1/2024
CyclophosphamideJ9073 Injection, cyclophosphamide (ingenus), 5 mg IngenusAlkylating AgentsMultipleYesAdd Code4/1/2024
CyclophosphamideJ9070* Cyclophosphamide, 100 mg ?Alkylating AgentsMultipleYesDiscontinue Code4/1/2024
CyclophosphamideJ9075 Injection, cyclophosphamide, not otherwise specified, 5mg ?Alkylating AgentsMultipleYesAdd Code4/1/2024
Methotrexate SodiumJ9250* Methotrexate sodium, 5 mg ?OncologyMultipleYesDiscontinue Code4/1/2024

Here is a general overview of the HCPCS Level II application and decision process:


1. Application Submission: Entities desiring a new code or code revision submit their applications to the CMS. This typically involves providing detailed information about the product or service, its medical necessity, how it differs from existing products or services, and why a new or revised code is necessary.

2. Preliminary Internal Review: Once received, the applications undergo an initial internal review by the CMS to ensure they are complete and meet the criteria for consideration.

3. Public Meetings: CMS typically conducts public meetings to discuss applications that have passed the preliminary review. During these meetings, the applicant, stakeholders, and the public can present their comments, recommendations, and any supporting evidence related to the application. These meetings ensure transparency and provide a platform for open discussion.

4. Primary Decision Factors: CMS takes into account several factors while making decisions. Some of these factors include:

  • Medical and clinical appropriateness
  • Whether the product or service is distinguishable from existing codes
  • The relevance for the Medicare population
  • Potential costs or savings for Medicare

5. Final Decision: After the public meetings and after considering all relevant data, CMS makes a decision. The outcomes can be:

  • Assignment of a new HCPCS code
  • Modification of an existing code
  • Disapproval of the application (with reasons provided)

6. Notification: Applicants are notified of the decision. Additionally, CMS publishes the decisions on its website, ensuring transparency and public accessibility.

7. Implementation: If a new code is assigned or an existing code is revised, it will be implemented on the date specified by the CMS. Providers and manufacturers should be aware of these dates to ensure accurate billing and reimbursement.

8. Annual Review: The CMS continuously reviews and updates the HCPCS codes to ensure they reflect current medical practices and technologies. As such, even after a code has been assigned or revised, it may be subject to future changes based on evolving needs and insights.

Understanding the processes by which the CMS HCPCS application and approval pathway works is crucial to the successful launch of a HCPCS coded drug.