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 Code||Brand Name||Company Name||Type||505(b)(2) Pathway||Long Description||Short Description||Effective Date|
|J0349||REZZAYO||Melinta Therapeutics||Establish Code||No||Injection, rezafungin, 1 mg||Inj, rezafungin, 1 mg||10/1/23|
|Mallinckrodt||Revise Code||No||Injection, corticotropin (acthar gel), up to 40 units||Inj. acthar gel to 40 units||10/1/23|
|J0802||Purified Cortrophin Gel||Ani Pharma||Revise Code||No||Injection, corticotropin (ani), up to 40 units||Inj. (ani), up to 40 units||10/1/23|
|J0874||DAPTOMYCIN||Baxter||Establish Code||Yes||Injection, daptomycin (baxter), not therapeutically equivalent to j0878, 1 mg||Inj, daptomycin (baxter)||10/1/23|
|J0889||JESDUVROQ||GSK||Establish Code||No||Daprodustat, oral, 1 mg, (for esrd on dialysis)||Daprodustat oral 1mg esrd||10/1/23|
|J2359||NA||NA||Establish Code||Yes||Injection, olanzapine, 0.5 mg||Inj. olanzapine, 0.5mg||10/1/23|
|J2781||SYFOVRE||Apellis||Establish Code||No||Injection, pegcetacoplan, intravitreal, 1 mg||Inj, pegcetacoplan, 1mg||10/1/23|
|J7214||ALTUVIIIO||Sanofi||Establish Code||No||Injection, factor viii/von willebrand factor complex, recombinant (altuviiio), per factor viii i.u.||Altuviiio per factor viii iu||10/1/23|
|J7353||NEXOBRID||Vericel Corporation||Establish Code||No||Anacaulase-bcdb, 8.8% gel, 1 gram||Anacaulase-bcdb 8.8% gel 1 g||10/1/23|
|J7519||NA||NA||Establish Code||Yes||Injection, mycophenolate mofetil, 10 mg||Inj. mycophenolate mofetil||10/1/23|
|J9051||Bortezomib||Maia Pharma||Establish Code||Yes||Injection, bortezomib (maia), not therapeutically equivalent to j9041, 0.1 mg||Inj, bortezomib (maia)||10/1/23|
|J9064||Cabazitaxel Injection||Sandoz||Establish Code||Yes||Injection, cabazitaxel (sandoz), not therapeutically equivalent to j9043, 1 mg||Inj, cabazitaxel (sandoz)||10/1/23|
|J9345||ZYNYZ||Incyte Pharma||Establish Code||No||Injection, retifanlimab-dlwr, 1 mg||Inj, retifanlimab-dlwr, 1 mg||10/1/23|
|A9573||Elucirem||Multiple||Establish Code||No||Injection, gadopiclenol, 1 ml||Inj, gadopiclenol, 1 ml||10/1/23|
|A9603||Pafolacianine||Hull Associates||Establish Code||No||Injection, pafolacianine, 0.1 mg||Inj, pafolacianine, 0.1 mg||10/1/23|
|A9697||Magtrace||Endomag||Establish Code||No||Injection, carboxydextran-coated superparamagnetic iron oxide, per study dose||Inj, magtrace per study dose||10/1/23|
C Code Approvals: Effective October 1st, 2023
|HCPCS Code||Type||505(b)(2) Pathway||Long Description||Short Description||Effective Date|
|C9152||Establish Code||No||Injection, aripiprazole, (abilify asimtufii), 1 mg||Inj, abilify asimtufii, 1 mg||10/1/23|
|C9153||Establish Code||No||Injection, amisulpride, 1 mg||Inj, amisulpride, 1 mg||10/1/23|
|C9154||Establish Code||No||Injection, buprenorphine extended-release (brixadi), 1 mg||Inj buprenorph (brixadi) 1mg||10/1/23|
|C9155||Establish Code||No||Injection, epcoritamab-bysp, 0.16 mg||Inj epcoritamab-bysp,0.16 mg||10/1/23|
|C9156||Establish Code||No||Flotufolastat f 18, diagnostic, 1 millicurie||Flotufolastat f18, dia 1 mci||10/1/23|
|C9157||Establish Code||No||Injection, tofersen, 1 mg||Inj, tofersen, 1 mg||10/1/23|
|C9158||Establish Code||No||Injection, risperidone, (uzedy), 1 mg||Inj, uzedy, 1 mg||10/1/23|
|C9788||Establish Code||No||Opto-acoustic imaging, breast (including axilla when performed), unilateral, with image documentation, analysis and report, obtained with ultrasound examination||Uni breas optoacoustic imag||10/1/23|
|C9789||Establish Code||No||Instillation of anti-neoplastic pharmacologic/biologic agent into renal pelvis, any method, including all imaging guidance, including volumetric measurement if performed||Instill pharm renal pelvis||10/1/23|
|C9790||Establish Code||No||Histotripsy (ie, non-thermal ablation via acoustic energy delivery) of malignant renal tissue, including image guidance||Kidney histotripsy w/image||10/1/23|
|C9791||Establish Code||No||Magnetic resonance imaging with inhaled hyperpolarized xenon-129 contrast agent, chest, including preparation and administration of agent||Mri hyperpolarized xenon129||10/1/23|
|C9792||Establish Code||No||Blinded 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 atrial||10/1/23|
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.