Pluvicto™ (lutetium Lu-177 vipivotide tetraxetan)

Question:
Could you please tell us how to code the new FDA approved (March 23, 2022) therapeutic injection procedure and radiopharmaceutical Pluvicto? This is for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based

Answer:

The coding for the new FDA approved therapeutic radiopharmaceutical Lutetium Lu-177 vipivotide tetraxetan, trade name Pluvicto™ will evolve as with any new drug. We expect this to continue over the next year or two and we encourage SNMMI members to check the SNMMI website regularly for updates. We also call to your attention that the various codes and reimbursement rates will change based on the billing setting, payer and date of service during this early evolution of a new drug. It is important to pay attention to the setting and payer; Medicare hospital outpatient, Medicare physician fee schedule, or third-party payers (TPP) and the date of service of the procedure for appropriate billing instructions.

Physician offices, and TPP should use HCPCS code A9699 Radiopharmaceutical, therapeutic, not otherwise classified for Lutetium Lu-177 vipivotide tetraxetan. When using HCPCS code A9699, be sure to include the 11-digit NDC on the claim form NDC # 69488-0010-61 for Pluvicto™. The appropriate unit of measure for an unlisted code is (1) one unit. Physician offices and IDTFs should work with the local carrier or private payers to educate them on the product, provide peer reviewed articles, and discuss adequate reimbursement. Invoice cost for Lutetium Lu-177 vipivotide tetraxetan is likely to be paid by many of the Medicare contractors in the office setting; however, there are some that continue to pay based on a percentage of AWP as listed in the Red Book or Medispan. Payment policy can vary among payers; therefore, you should check with your individual payers for their policies on how they pay for diagnostic radiopharmaceuticals.

For dates of service immediate post-FDA approval (beginning March 23, 2022), hospital outpatient departments should bill Medicare for Lutetium Lu-177 vipivotide tetraxetan using HCPCS code C9399 Unclassified drugs or biological for Pluvicto™ as it is a new FDA approved therapeutic radiopharmaceutical without a more specific HCPCS code. The appropriate unit of measure for an unlisted code is (1) one unit which equates to per treatment dose. When using HCPCS code C9399, be sure to include NDC # 69488-0010-61 for Pluvicto™ on the claim form so that the payer can identify the therapeutic radiopharmaceutical.

Regarding the Radiopharmaceutical Coding, for claims, with a DOS on or after October 1, 2022, in all settings use A9607 GLutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie. We caution you regarding the code description of “per millicurie”, rather than per study or per treatment dose, therefore, be sure you list the number of millicuries administered and any waste following the waste guidance and the JW modifier.

More information on waste coding and billing see the revised Q&A: http://www.snmmi.org/IssuesAdvocacy/QandADetail.aspx?ItemNumber=1861&navItemNumber=24950

Of note, effective for claims with DOS on or after January 1, 2017, Medicare requires the use of the JW modifier for wasted drugs or radiopharmaceuticals. Additionally, effective for claims with DOS on or after July 1, 2023, Medicare requires the use of JW and JZ for single use drugs or radiopharmaceuticals for tracking and payment. For more information and CMS Q&A on the JW and JZ modifiers go to https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf

The opinions referenced are those of the members of the SNMMI Coding and Reimbursement Committee and their consultants based on their coding experience. They are based on the commonly used codes in Nuclear Medicine, which are not all inclusive. Always check with your local insurance carriers as policies vary by region. The final decision for the coding of a procedure must be made by the physician considering regulations of insurance carriers and any local, state or federal laws that apply to the physicians practice. The SNMMI and its representatives disclaim any liability arising from the use of these opinions.