HCPCS Code Applications and Approvals

Effective July 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 July 1st, 2024

*Not Including Q4 skin repair/wound codes*

Drug NameHCPCSHCPCS Code DescriptorCompanyDrug TypeROA505(b)(2)?TypeEffective Date
WEZLANAQ5137Injection, ustekinumab-auub (wezlana),
biosimilar, subcutaneous, 1 mg
Amgeninterleukin inhibitorsubcutaneousNoAdd Code7/1/24
WEZLANAQ5138Injection, ustekinumab-auub (wezlana),
biosimilar, intravenous, 1 mg”
Amgeninterleukin inhibitorintravenousNoAdd Code7/1/24
LOQTORZIJ3263Injection, toripalimab-tpzi, 1 mgCoherus Biosciencesmonoclonal antibodyintravenousNoAdd Code7/1/24
ZYMFENTRAQ5136Injection, infliximab-dyyb (zymfentra),
biosimilar, 10 mg
CelltrionTNF alfa inhibitorsintravenousNoAdd Code7/1/24
OMVOHJ2267Injection, mirikizumab-mrkz, 1 mgEli Lilly and Companyinterleukin-23p19 antagonistintravenousNoAdd Code7/1/24
ADZYNMAJ7171Injection, adamts13, recombinant-krhn, 10 iuTakedadisintegrin and metalloproteinaseintravenousNoAdd Code7/1/24
RyzneutaJ9361Injection, efbemalenograstim alfa-vuxw, 0.5
mg
Acrotech Biopharmahaematopoietic growth factorssubcutaneousNoAdd Code7/1/24
ZYNTEGLOJ3393Injection, betibeglogene autotemcel, per
treatment
bluebird bioautologous hematopoietic stem cell-based gene therapyintravenousNoAdd Code7/1/24
LYFGENIAJ3394Injection, lovotibeglogene autotemcel, per
treatment
bluebird bioautologous hematopoietic stem cell-based gene therapyintravenousNoAdd Code7/1/24
COSENTYXJ3247Injection, secukinumab, intravenous, 1 mgNovartismonoclonal antibodyintravenousNoAdd Code7/1/24
Daptomycin for Injection (room temperature)J0872Injection, daptomycin (xellia), unrefrigerated,
not therapeutically equivalent to j0878 or j0873, 1 mg
Xelliacyclic lipopeptide antibioticintravenousYesAdd Code7/1/24
Daptomycin for Injection (refrigerated)J0873 Injection, daptomycin (xellia),
not therapeutically equivalent to j0878 or j0872, 1 mg
Xelliacyclic lipopeptide antibioticintravenousYesRevise Code7/1/24
iDose TRJ7355Injection, travoprost, intracameral implant, 1
microgram
Glaukosprostaglandin analogintracamerallyNoAdd Code7/1/24
DEFENCATHJ0911Instillation, taurolidine 1.35 mg and heparin
sodium 100 units (central venous catheter lock for esrd on dialysis)
CorMedixantimicrobial CLScentral venous catheterNoAdd Code7/1/24
Palonosetron HydrochlorideJ2468Injection, palonosetron hcl (Avyxa) not
therapeutically equivalent to J2469, 25 mcg
Avyxa5-HT3 receptor antagonistsintravenousYesAdd Code7/1/24
Micafungin in Sodium ChlorideJ2246Injection, micafungin in sodium (baxter), not
therapeutically equivalent to j2248, 1 mg
BaxterantifungalintravenousYesAdd Code7/1/24
ABILIFY MAINTENAJ0401Injection, aripiprazole (abilify maintena), 1 mgOtsuka Americatypical antipsychoticsintramuscularNoRevise Code7/1/24
RanitidineJ2780Injection, ranitidine hydrochloride, 25
mg
H2 blockersintravenousNoDiscontinue Code7/1/24

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.