HCPCS Code J2323: Injection, Natalizumab, 1 mg

Learn about the HCPCS code J2323 for injection, natalizumab, 1 mg, through this short guide.

## **What is the HCPCS code J2323 for?** The HCPCS code J2323 is a J code, which means it's part of a massive cluster of codes that are mostly used to designate injected medication. For this code in particular, what is being injected is a 1 mg dose of natalizumab, which is commonly referred to as a Tysabri or Tyruko injection. Please note that this isn't an injection for chemotherapy administration. Natalizumab is an immunotherapy injection administered intravenously, and it is the first non-tumor necrosis factor alpha antagonist approved for the treatment of (severely active) Crohn's disease. According to the National Multiple Sclerosis Society, it's also used to treat a relapsing-remitting disease, specifically relapsing-remitting multiple sclerosis (RRMS), clinically isolated syndrome (CIS), and secondary progressive multiple sclerosis. If any of these are confirmed to be an aggressive initial disease, natalizumab treatment is sometimes used as an initial therapy. What this medicine does is reduce inflammation and prevent immune cells (T and B cells) from attacking and damaging myelin, which protects the nerves of our spinal cords and brains . This injected medication has undergone controlled clinical trials and has been confirmed to induce and maintain clinical responses as well as remission in natalizumab-treated patients who have moderate or severe active Crohn's disease with inflammation. It can prevent RRMS or Crohn's disease severity from getting worse, and reduce clinical exacerbations and the clinical relapse rate of those diseases (Polman et al., 2006). However, it was withdrawn from the Crohn's disease market in 2009 due to safety concerns and then re-launched with stricter prescribing guidelines (Shirani & Stüve, 2018).

## **Documentation requirements for J2323** As with any procedure, it's important to document the following before you file for a claim that includes this HCPCS code: - The full name of the personnel who administered the injection + their credentials - The name and address of the facility where the injection was administered, plus the NDC code of the injection - The full name of the (adult) patient - The date and time of the drug administration by injection - Patient records showing they have been diagnosed with Crohn's disease, multiple sclerosis, or clinically isolated syndrome - Patient records showing if they've had or are currently on disease-modifying therapies - Blood test results to check for other contraindications or infections - MRI results, if the patient treated with natalizumab has multiple sclerosis - Infusion start and stop times - Documentation of the patient's tolerance or intolerance to the medicine, and other post-infusion observation findings

## **Billing requirements for J2323** Besides the documentation requirements above, please note the following billing requirements for this HCPCS code: - The exact dosage given over the course of the treatment. In this case, 1 mg = 1 unit - Use either of two modifiers: JW if there's unused medication in a vial (wastage), or JZ if there's no unused medication. - The ICD codes specific to the patient's disease - CPT code 96365 because this injection is administered intravenously Please make sure you follow CMS coding guidelines before submitting your claim to prevent claim rejections.

## **Other similar codes** - **J3380** - Injection, vedolizumab, 1 mg - **J3262** - Injection, tocilizumab, 1 mg - **J9299** - Injection, nivolumab, 1 mg - **J2350** - Injection, ocrelizumab, 1 mg - **J2182** - Injection, mepolizumab, 1 mg

### **Reference** Shirani, A., & Stüve, O. (2018). Natalizumab: Perspectives from the bench to bedside. Cold Spring Harbor Perspectives in Medicine, 8(12), a029066. https://doi.org/10.1101/cshperspect.a029066 Polman, C. H., O’Connor, P. W., Havrdova, E., Hutchinson, M., Kappos, L., Miller, D. H., Phillips, J. T., Lublin, F. D., Giovannoni, G., Wajgt, A., Toal, M., Lynn, F., Panzara, M. A., & Sandrock, A. W. (2006). A randomized, Placebo-Controlled trial of natalizumab for relapsing multiple sclerosis. New England Journal of Medicine, 354(9), 899–910. https://doi.org/10.1056/nejmoa044397

Frequently asked questions

All injected medication will likely result in pain and discomfort in the injection site. In the case of natalizumab therapy, it's possible for the patient to feel fatigued, experience headaches, and have joint pain. Rarely, it may increase the risk of opportunistic viral infections like progressive multifocal leukoencephalopathy (PML). Another potential rare complication is an allergic reaction. You need to observe the patient after the infusion.

The effects are not felt immediately. For some patients, the benefits are noticeable a few weeks after the infusion. For some, it takes months.

The whole procedure, if you include observation time, will take approximately two hours.