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October 19, 2021Revised 09/08/2023

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 gozetotide) and F-18-flotufolastat (Posluma)

On March 23, 2022 the Food and Drug Administration (FDA) approved Gallium 68 PSMA-11. On May 26, 2021, the FDA approved Pylarify. In May 2023 the FDA approved F-18-flotufolastat.

Gallium 68 PSMA-11 and Pylarify are a 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 F-18-flotufolastat 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 FDA indication and usage for Gallium 68 gozetotide:

  • 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

Claims prior to 1/1/2022 use A9597 – PET radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified.

For Pylarify as of January 1, 2022 use HCPCS code:

  • A9595 HCPCS Level II code PYLARIFY Piflufolastat f-18, diagnostic, 1 millicurie.

For Gallium 68 PSMA-11 (Ga 68 PSMA-11) should be billed with:

  • A9593 HCPCS code for Gallium ga-68 psma-11, diagnostic, (ucsf), 1 millicurie
  • A9594 HCPCS for Gallium ga-68 psma-11, diagnostic, (ucla), 1 millicurie
  • A9597 HCPCS for Gallium Ga-68 Gozetotide (68Ga-PSMA-11) until 6/30/22
  • A9596 HCPCS for Gallium Ga-68 Gozetotide (68Ga-PSMA-11) "Illuccix" effective 7/1/22
  • A9800 HCPCS for Gallium Ga-68 Gozetotide, "Locametz", 1 millicurie

For F-18-flotufolastat as of 8/28/23 there is no specific Level II HCPCS assigned to this agent. Until a specific HCPCS code is assigned providers and suppliers may bill using:

A9597 – PET radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified.

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:

  • Rationale for why metastasis is suspected.
  • 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.

Future products that are approved by the FDA must be used according to the FDA approved indications with billing instructions above per those indications.

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