PYLARIFY™ (F-18 labeled piflufolastat, Injection)

Question:
Could you please tell us how to code the new FDA-approved (May 27, 2021) radiopharmaceutical F-18 piflufolastat injection (PYLARIFY™), a PET imaging of prostate-specific membrane antigen (PSMA) positive lesions in men 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?

Answer:

The coding for the new FDA-approved diagnostic radiopharmaceutical F-18 piflufolastat 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 May 31, 2016, for all Medicare settings, imaging with F-18 piflufolastat 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 (beginning on or after May 27, 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 F-18 piflufolastat . When using HCPCS code A9597, be sure to include the NDC 71258-0022-00 on the claim form so that the payer can identify the drug more easily. Providers should work with the private payers to educate them on the product, provide peer-reviewed literature, and discuss adequate reimbursement. For claims with a DOS January 1, 2022, and beyond use HCPCS Level II code A9595 Piflufolastat f-18, diagnostic, 1 millicurie. Payment policy can vary among payers; therefore, you should check with your individual payers for their policies on how they pay for diagnostic radiopharmaceuticals. 

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.