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Last Modified: 6/6/2024 Location: FL, PR, USVI Business: Part B

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) 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.

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®)
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.
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