Subscribe to eNews Contact us / IVR

Radioactive diagnostic agents for positron emission tomography of prostate-specific membrane antigen positive lesions in men with prostate cancer

Piflufolastat F-18 (PYLARIFY) and Gallium Ga 68 gozetotide (LOCAMETZ) (ILLUCCIX), Gozellix, and Flotufolastat F-18 (POSLUMA®) are radioactive diagnostic agents indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions, in men with prostate cancer.

Pylarify 

  • Approved by the FDA for the following indications effective May 26, 2021:

    • PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy

    • PSMA positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels

Locametz

  • Approved by the FDA for the following indications effective March 23, 2022:

    • PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy

    • PSMA positive lesions in men with prostate cancer with suspected recurrence based on elevated serum PSA level

    • For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

Illuccix 

  • Approved by the FDA for the following indications effective December 17, 2021:

    • PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy

    • PSMA positive lesions in men with prostate cancer with suspected recurrence based on elevated serum PSA level

    • For selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

Posluma

  • Approved by the FDA for the following indications effective May 25, 2023:

    • PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy

    • PSMA positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels

Note: A PSMA PET scan should not be used without prostate cancer present. Providers must report all ICD-10 codes that together most appropriately describe the patient’s clinical condition, symptoms, and documented findings. Generally, a combination of ICD-10 codes will be needed to assure the clinical scenario aligns with FDA label indications and well-accepted appropriate use criteria for PSMA focused diagnostic PET scans.

Gozellix

  • After radiolabeling with Ga 68, is a radioactive diagnostic agent approved by the FDA effective October 1, 2025, and indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with:
    • PSMA positive lesions in men with prostate cancer
    • Suspected metastasis who are candidates for initial definitive therapy
    • Suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

Correct coding

  • Report A9595 for Piflufolastat F-18 (PYLARIFY®)

  • Report A9800 for Gallium Ga 68 gozetotide (LOCAMETZ®)

  • Report A9596 for Gallium Ga 68 gozetotide (ILLUCCIX®)

  • Report A9608 for Flotufolastat F-18 (POSLUMA®)
  • Report A9616 for Gozellix

  • PET scan claims will reject if a tracer code is not billed for the same date of service and vice versa. If either of the codes (PET scan or tracer) is denied / not covered, the other code will also be denied

  • Diagnosis / diagnoses reported on the claim must reflect an FDA approved indication

Required modifiers

  • PI: PET / computed tomography (CT) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing

  • PS: PET / CT to inform the subsequent treatment strategy of cancerous tumors when the beneficiary's treating physician determines that the PET study is needed to inform subsequent antitumor strategy

Note: The KX modifier is not required.

References