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October 19, 2021 - Revised 01/20/2022

Radioactive Diagnostic Agents for Positron Emission Tomography (PET) of Prostate-Specific Membrane Antigen (PSMA) Positive Lesions in Men with Prostate Cancer Billing and Coding Instructions

Piflufolastat (F-18) ("Pylarify) )(18F-DCFPyl or PyL) and Gallium 68 PSMA-11 (Ga 68 PSMA-11)

On December 01, 2020 the Food and Drug Administration (FDA) approved Gallium 68 PSMA-11 to the University of California, Los Angeles and the University of California, San Francisco. On May 26, 2021, the FDA approved Pylarify.

Gallium 68 PSMA-11 and Pylarify are radioactive diagnostic agents, indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

The FDA indication and usage for Pylarify and Gallium 68 PSMA-11 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.

Claims prior to date of service January 1, 2022, use HCPCS Code A9597 – PET radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified.

For Pylarify, use HCPCS Level II code for dates of service on and after January 1, 2022:

  • A9595 - PYLARIFY Piflufolastat f-18, diagnostic, 1 millicurie.

For Gallium 68 PSMA-11 (Ga 68 PSMA-11), current approval is limited to the University of California, Los Angeles and the University of California, San Francisco as of January 1, 2022. Use HCPCS Level II codes:

  • A9593 - Gallium ga-68 psma-11, diagnostic, (ucsf), 1 millicurie
  • A9594 - Gallium ga-68 psma-11, diagnostic, (ucla), 1 millicurie

Note: This has been added to allow in an independent diagnostic testing facility (IDTF).

As this marker would not be used without prostate cancer present, one of the following ICD-10 codes would be expected to be on the claim:

  • C61 - Malignant neoplasia of prostate
  • R97.21 - Rising PSA following treatment for malignant neoplasia of prostate
  • C79.82 - Secondary malignant neoplasm of genital organs must be billed accompanied by C61

Note: ICD-10 code Z85.46 (Personal history of malignant neoplasm of prostate) is not sufficient and must be accompanied by C61 or R97.21.

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 test.

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 anti-tumor strategy.

  • Use HCPCS modifier PI for PET or PET/CT CPT codes when billing to inform the initial treatment strategy with C61.
  • Use HCPCS modifier PS for PET or PET/CT CPT codes when billing to inform the subsequent treatment with C61 with R97.21, or C61 with C79.82.

Documentation Requirements:

Use in initial definitive therapy

The FDA label limits use for initial definitive therapy for patients with suspected metastasis. The National Comprehensive Cancer Network (NCCN) provides clinical guidance on candidacy for initial use of PSMA PET CT/MRI scans.

The medical record must include:

  1. Rationale for why metastasis is suspected.
  2. Why initial imaging is indicated such as:
    1. Bone scan is equivocal for initial disease
    2. Unfavorable intermediate risk, high and very high-risk prostate cancer group as an alternative to standard imaging of bone scan and soft tissue for initial staging for patients at risk for bone and/or soft tissue disease.

Use in suspected recurrence

The FDA limits to suspected recurrence-based history with elevated serum prostate-specific antigen (PSA) levels. Therefore, both diagnosis of prostate cancer and elevated PSA levels must be documented in medical record.

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