Detectnet™ Copper (Cu-64) DOTATATE Injection

Question:
Could you please tell us how to code RadioMedix and Curium’s new FDA-approved (September 3, 2020) radiopharmaceutical, Detectnet™ Copper Cu 64 DOTATATE injection, indicated for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients?

Answer:

The coding for a new FDA-approved diagnostic radiopharmaceutical could evolve as with any new drug or new therapeutic radiopharmaceutical. 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 (NCD) 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 September 3, 2020, for all Medicare settings, imaging with Cu-64 DOTATATE may be 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.

Regarding the Radiopharmaceutical Coding, for DOS immediate post-FDA approval (beginning on or after September 3, 2020 to March 31, 2021), hospital outpatient departments, IDTFs, physician offices, and TPPs use HCPCS Level II code A9597 Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified for Cu-64 DOTATATE. When using HCPCS code A9597, be sure to include the NDC (69945-0064-01) 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. For hospital outpatient departments ONLY and for claims with a DOS from January 1, 2021 to March 31, 2021, use code C9068-Copper Cu-64, dotatate, diagnostic, 1 millicurie. For Hospitals, HCPCS level II code C9068 (to be followed later by it permanent HCPCS level II code A9592) has received transitional pass-through status code "G '' with a rate of $901.25 per millicurie. Therefore, for all payers, HOPPS, IDTF, physician offices and TPP for DOS April 1, 2021 and beyond use the HCPCS code A9592 Copper Cu-64, dotatate, diagnostic, 1 millicurie. For up-to-date information on reimbursement, please click here.

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.