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October 19, 2021Revised 08/30/2024

Billing & Coding Instructions: Radioactive Diagnostic Agents for PET of PSMA Positive Lesions in Men with Prostate Cancer

The Food and Drug Administration (FDA) approved:

  • Piflufolastat (F-18) (Pylarify) (18F-DCFPyl or PyL) on May 26, 2021.
  • Gallium 68 PSMA-11 (Ga 68 gozetotide) on March 23, 2022.
  • F-18-flotufolastat (Posluma) in May 2023.

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

FDA Indication & Usage

Pylarify and F-18-flotufolastat

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.

Gallium 68 gozetotide

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

Billing & Coding Instructions

HCPCS Codes

Use the appropriate HCPCS code as indicated below:

  • For claims prior to January 1, 2022:
    • A9597 (PET radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified)
  • Pylarify:
    • As of January 1, 2022:
      A9595 (Piflufolastat f-18, diagnostic, 1 millicurie)
  • Gallium 68 PSMA-11 (Ga 68 PSMA-11):
    • A9593 (Gallium ga-68 psma-11, diagnostic, (ucsf), 1 millicurie)
    • A9594 (Gallium ga-68 psma-11, diagnostic, (ucla), 1 millicurie)
    • A9597 (Gallium ga-68 gozetotide (68Ga-PSMA-11)); effective through 6/30/22
    • A9596 (Gallium ga-68 gozetotide, diagnostic, (illuccix), 1 millicurie); effective 7/1/22
    • A9800 (Gallium ga-68 gozetotide, diagnostic, (locametz), 1 millicurie)
  • F-18-flotufolastat (Posluma):
    • Prior to January 1, 2024:
      A9597 (PET radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified)
    • HCPCS code A9597 is also allowed in an independent diagnostic testing facility (IDTF) setting.
    • Since this marker is not used without prostate cancer present, one of the following ICD-10 codes is expected on the claim:
      • C61 (Malignant neoplasm of prostate)
      • R97.21 (Rising PSA following treatment for malignant neoplasm of prostate)
      • C79.82 (Secondary malignant neoplasm of genital organs) must accompany C61.
      • Note: Z85.46 (Personal history of malignant neoplasm of prostate) is not sufficient and must accompany C61 or R97.21.
    • As of January 1, 2024:
      A9608 (Flotufolastat f-18, diagnostic, 1 millicurie)

Modifiers

Use the appropriate HCPCS modifier as indicated below:

  • For PET or PET/CT procedure codes billed to inform the initial treatment strategy with ICD-10 code C61:
    • PI (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)
  • For PET or PET/CT procedure codes billed to inform the subsequent treatment with ICD-10 codes C61 and R97.21 or C61 and C79.82:
    • PS (PET or 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 anti-tumor strategy)

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:
    • Bone scan is equivocal for initial disease.
    • 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 PSA levels. Therefore, medical record documentation must indicate both diagnosis of prostate cancer and elevated PSA levels.

Future products that receive FDA approval must be used according to the FDA-approved indications and associated billing instructions above.

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