HCPCS Code Applications and Approvals

Effective October 1st, 2023

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 a HCPCS applications submitted in quarter 2 is decided upon and becomes effective in quarter four. Below, BuyandBill has published two tables related to the HCPCS code applications and approvals

Table 1: CMS Level II HCPCS Coding Decisions (Effective October 1st, 2023)

Table 2: C Code Approvals (Effective: October 1st, 2023)

CMS Level II HCPCS Coding Decisions: Effective October 1st, 2023

HCPCS CodeBrand NameCompany NameType505(b)(2) PathwayLong DescriptionShort DescriptionEffective Date
J0349REZZAYOMelinta TherapeuticsEstablish CodeNoInjection, rezafungin, 1 mgInj, rezafungin, 1 mg10/1/23
MallinckrodtRevise CodeNoInjection, corticotropin (acthar gel), up to 40 unitsInj. acthar gel to 40 units10/1/23
J0802Purified Cortrophin GelAni PharmaRevise CodeNoInjection, corticotropin (ani), up to 40 unitsInj. (ani), up to 40 units10/1/23
J0874DAPTOMYCINBaxterEstablish CodeYesInjection, daptomycin (baxter), not therapeutically equivalent to j0878, 1 mgInj, daptomycin (baxter)10/1/23
J0889JESDUVROQGSKEstablish CodeNoDaprodustat, oral, 1 mg, (for esrd on dialysis)Daprodustat oral 1mg esrd10/1/23
J2359NANAEstablish CodeYesInjection, olanzapine, 0.5 mgInj. olanzapine, 0.5mg10/1/23
J2781SYFOVREApellisEstablish CodeNoInjection, pegcetacoplan, intravitreal, 1 mgInj, pegcetacoplan, 1mg10/1/23
J7214ALTUVIIIOSanofiEstablish CodeNoInjection, factor viii/von willebrand factor complex, recombinant (altuviiio), per factor viii i.u.Altuviiio per factor viii iu10/1/23
J7353NEXOBRIDVericel CorporationEstablish CodeNoAnacaulase-bcdb, 8.8% gel, 1 gramAnacaulase-bcdb 8.8% gel 1 g10/1/23
J7519NANAEstablish CodeYesInjection, mycophenolate mofetil, 10 mgInj. mycophenolate mofetil10/1/23
J9051BortezomibMaia PharmaEstablish CodeYesInjection, bortezomib (maia), not therapeutically equivalent to j9041, 0.1 mgInj, bortezomib (maia)10/1/23
J9064Cabazitaxel InjectionSandozEstablish CodeYesInjection, cabazitaxel (sandoz), not therapeutically equivalent to j9043, 1 mgInj, cabazitaxel (sandoz)10/1/23
J9345ZYNYZIncyte PharmaEstablish CodeNoInjection, retifanlimab-dlwr, 1 mgInj, retifanlimab-dlwr, 1 mg10/1/23
A9573EluciremMultipleEstablish CodeNoInjection, gadopiclenol, 1 mlInj, gadopiclenol, 1 ml10/1/23
A9603PafolacianineHull AssociatesEstablish CodeNoInjection, pafolacianine, 0.1 mgInj, pafolacianine, 0.1 mg10/1/23
A9697MagtraceEndomagEstablish CodeNoInjection, carboxydextran-coated superparamagnetic iron oxide, per study doseInj, magtrace per study dose10/1/23

C Code Approvals: Effective October 1st, 2023

HCPCS CodeType505(b)(2) PathwayLong DescriptionShort DescriptionEffective Date
C9152Establish CodeNoInjection, aripiprazole, (abilify asimtufii), 1 mgInj, abilify asimtufii, 1 mg10/1/23
C9153Establish CodeNoInjection, amisulpride, 1 mgInj, amisulpride, 1 mg10/1/23
C9154Establish CodeNoInjection, buprenorphine extended-release (brixadi), 1 mgInj buprenorph (brixadi) 1mg10/1/23
C9155Establish CodeNoInjection, epcoritamab-bysp, 0.16 mgInj epcoritamab-bysp,0.16 mg10/1/23
C9156Establish CodeNoFlotufolastat f 18, diagnostic, 1 millicurieFlotufolastat f18, dia 1 mci10/1/23
C9157Establish CodeNoInjection, tofersen, 1 mgInj, tofersen, 1 mg10/1/23
C9158Establish CodeNoInjection, risperidone, (uzedy), 1 mgInj, uzedy, 1 mg10/1/23
C9788Establish CodeNoOpto-acoustic imaging, breast (including axilla when performed), unilateral, with image documentation, analysis and report, obtained with ultrasound examinationUni breas optoacoustic imag10/1/23
C9789Establish CodeNoInstillation of anti-neoplastic pharmacologic/biologic agent into renal pelvis, any method, including all imaging guidance, including volumetric measurement if performedInstill pharm renal pelvis10/1/23
C9790Establish CodeNoHistotripsy (ie, non-thermal ablation via acoustic energy delivery) of malignant renal tissue, including image guidanceKidney histotripsy w/image10/1/23
C9791Establish CodeNoMagnetic resonance imaging with inhaled hyperpolarized xenon-129 contrast agent, chest, including preparation and administration of agentMri hyperpolarized xenon12910/1/23
C9792Establish CodeNoBlinded or nonblinded procedure for symptomatic new york heart association (nyha) class ii, iii, iva heart failure; transcatheter implantation of left atrial to coronary sinus shunt using jugular vein access, including all imaging necessary to intra procedurally map the coronary sinus for optimal shunt placement (e.g., tee or ice ultrasound, fluoroscopy), performed under general anesthesia in an approved investigational device exemption (ide) study)Blind/nonblind trans atrial10/1/23

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.