Locametz® (gallium Ga-68 gozetotide, Injection)

Question:
Could you please tell us how to code the new FDA-approved (March 23, 2022) diagnostic radiopharmaceutical Gallium 68 gozetotide, injection, indicated for positron emission tomography (PET) of PSMA-positive lesions in adult patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy; with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level; and for selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Answer:

The coding for the new FDA-approved diagnostic radiopharmaceutical Ga-68 gozetotide will evolve as with any new drug. We expect this evolution to occur over the next year or two and we encourage SNMMI members to check SNMMI's website regularly for updates. We also call to your attention that the various codes and reimbursement rates will change based on the billing setting and date of service during this early evolution of a new drug and service. It is important to pay attention to the setting; Medicare hospital outpatient, Medicare physician fee schedule, independent diagnostic testing facilities (IDTF), or third-party payers (TPP) and the date of service (DOS) of the procedure for appropriate billing instructions.

Of importance, Medicare currently has a National Coverage Determination for Oncologic PET procedures which allows local contractors to determine coverage for newly approved by FDA PET agents; therefore, for claims with a DOS on or after March 23, 2022 for all Medicare settings, imaging with Ga-68 gozetotide is covered at the local Medicare Administrative Contractor (MAC) discretion, providers should communicate with their local MAC for local coverage policies pertaining to this new diagnostic radiopharmaceutical and procedure. To bill Medicare for locally covered PET services, use the single most appropriate CPT code 78811 to 78816 based on the imaging area and PET/CT or PET equipment ordered and used for the study. To bill Medicare in any setting for non-covered PET services, providers would choose HCPCS Level II code G0235 PET imaging, any site, not otherwise specified. Billing Medicare with this code should result in a claim denial. Providers who choose to have their patients sign Advanced Beneficiary Notices, prior to performing the studies, could then bill the patient for the non-covered Medicare service. However, in general we expect payers to pay absent negative coverage policies.

Regarding the Radiopharmaceutical Coding, for DOS immediate post-FDA approval (from March 23, 2022), hospital outpatient departments IDTFs, physician offices, and TPPs use HCPCS Level II code A9598 Positron emission tomography radiopharmaceutical, diagnostic, for non-tumor identification, not otherwise classified for F-18 Ga-68 gozetotide. When using HCPCS code A9598, be sure to include the NDC Manufacturer: Norvartis (NDC#: 69488-0017-61) on the claim form so that the payer can identify the drug more easily. Some payers may request J3490 Unclassified drugs which is another unlisted drug code, so do check with the local payer to report the correct temporary billing HCPCS code.

Regarding the Radiopharmaceutical Coding, for claims, with a DOS on or after October 1, 2022, in all settings use A9800 Gallium Ga-68 gozetotide, diagnostic, (Locametz), 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.