Radioactive Diagnostic Agents for Positron Emission Tomography of Prostate-Specific Membrane Antigen Positive Lesions in Men with Prostate Cancer

Published 09/18/2024

The following are radioactive diagnostic agents that have been FDA approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions, in men with prostate cancer:

The FDA indications for piflufolastat F 18 (PYLARIFY®) are:

  • SMA 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) levels

The FDA indications for Gallium Ga 68 gozetotide (Locametz®), Illuccix®) are:

  • With suspected metastasis who are candidates for initial definitive therapy
  • With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
  • For selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

The FDA indications for flotufolastat F 18 (Posluma) are:

  • 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) levels

The appropriate radiopharmaceutical HCPCS code is expected to be reported on the same date of service as the PSMA PET scan.

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.

Code 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 reported on the claim must reflect an FDA approved indication

Required Modifiers

HCPCS modifier PI: Positron Emission Tomography (PET) or 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.

HCPCS modifier PS: Positron Emission Tomography (PET) or PET/Computed Tomography (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.

Documentation Requirements

The National Comprehensive Cancer Network (NCCN) provides clinical guidance on candidacy for initial use of PSMA PET CT/MRI scans. Per FDA indications for these radiopharmaceuticals with PSMA scans, documentation should be present to support the underlying indication. In the case of suspected metastases, documentation should explain why this concern exists and what objective testing has previously been performed to support the concern. In the case of suspected recurrence of prostate cancer, the documentation of that clinical scenario should also be evident in the medical record.

The medical record must include:

  • Rationale for why metastasis is suspected along with any additional objective imaging or laboratory results or patient history that supports the clinical suspicion;
  • Trending elevated or clinically inappropriately elevated PSA results;
  • Prior relevant prostate biopsy results and documentation regarding patient’s risk of recurrence;
  • Life expectancy;
  • Associated clinical symptoms or exam findings; and
  • Why PSMA imaging is a desirable diagnostic approach for initial staging or biochemical recurrence

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