CurrentKaiser PermanentePolicy N/A

Kaiser Permanente Clinical Review Criteria for PSMA PET/CT Imaging Guidelines for Prostate Cancer

Clinical review criteria defining medical necessity for PSMA PET/CT imaging (including Pylarify, Ga-68 and other FDA-approved PSMA tracers) for prostate cancer for Kaiser Foundation Health Plan of Washington members; includes criteria for initial staging, biochemical recurrence/treatment-specific re-staging, surveillance, and code applicability. Axumin (fluciclovine) PET is no longer recommended.

Policy Summary

PayerKaiser Permanente

PolicyKaiser Permanente Clinical Review Criteria for PSMA PET/CT Imaging Guidelines for Prostate Cancer

Policy CodePolicy N/A

Change TypeCriteria added/modifiedcodes updated

Effective DateJun 1, 2023

Next Review Date

Key ActionInclude conventional imaging reports (CT and/or bone scan within last 2 months) and the last 6 months of clinical notes when submitting requests to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

MPC approved coverage criteria for PSMA (Pylarify, Gallium-68 and other FDA approved PSMA tracers) PET/CT Imaging Guidelines for Prostate Cancer, with Axumin PET no longer recommended; effective June 01, 2023.

Updated applicable new codes to include A9800 and updated references to include TheraP and VISION trials.

MPC approved modified criteria for PET PSMA for commercial members and applied modified criteria to Medicare reviews; effective June 1, 2025.

Added retired PET scan NCD 220.6 link and clarifying language that KPWA commercial policy may supplement retired Medicare NCD for PSMA PET reviews.

Planned applicable codes update dated 09/25/2025 (future noted).

1Primary policy focus (PSMA PET/CT)

Axumin PETRecommendation status

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<=5Oligometastatic lesion count used to consider focal therapy

Coverage Summary

This policy defines medical necessity criteria for PSMA PET/CT imaging (including Pylarify, Ga-68 and other FDA‑approved PSMA tracers) for Kaiser Foundation Health Plan of Washington members. Coverage stance is mixed: PSMA PET/CT is considered medically necessary in specified clinical scenarios (initial staging, select cases of biochemical recurrence and treatment‑specific re‑staging) when the policy criteria are met, but not for routine surveillance or restaging requests that do not meet the criteria. The rationale is that PSMA radiotracer PET/CT improves detection and characterization of metastatic prostate cancer compared to conventional imaging yet evidence that PSMA imaging improves health outcomes is currently limited. Axumin (fluciclovine) PET is no longer recommended by this policy. Status: CURRENT. Effective date: 2023-06-01 (initial MPC approval 01/09/2023); latest modification effective 2025-06-01 per MPC approval 01/14/2025; last reviewed 2025-02-25.

Key thresholds and quick facts

PSA threshold (post-prostatectomy serologic relapse)>= 0.5 ng/mL

PSA threshold (post-radiation, Phoenix criteria)>= 2.0 ng/mL above nadir on two separate occasions

PSA doubling time (PSADT)Approximately 2–3 months (used to consider PSMA PET in lower PSA scenarios); PSADT most accurate for PSA > 1 ng/mL

Oligometastatic lesion count for focal therapy considerationGenerally <= 5 lesions

Axumin (fluciclovine) statusAxumin PET is no longer recommended

Medical-Necessity Criteria — Initial Staging

Initial Staging / Assessment for Metastatic Disease (Non-Medicare Members)

PSMA PET/CT can be considered when ALL of the following apply unless conventional imaging already detected metastatic disease:

ALL of the following

Patient undergoing initial staging evaluation and assessment for metastatic disease
Conventional imaging has NOT already detected presence of metastatic disease

Initial Staging - Equivocal/Indeterminate Conventional Imaging

PSMA PET/CT can be considered when ALL of the following are met:

ALL of the following

Medical-Necessity Criteria — Biochemical Recurrence and Re-staging

Not Medically Necessary / Surveillance

Surveillance and Other Restaging

PSMA PET/CT can be considered for biochemical recurrence or re-staging when ALL applicable criteria below are met (specific branches for post-prostatectomy serologic relapse, post-radiation relapse, PSADT criteria, and oligometastatic-directed therapy planning):

Any of the following clinical scenarios

Serologic relapse after surgery (post-prostatectomy)
- PSA >= 0.5 ng/mL>= 0.5 ng/mL
- Conventional imaging with CT and/or bone scan performed within the last 2 months (if not done, it should be performed first)within 2 months

Coding

Applicable CPT (PET) codesCPT

78811	Positron emission tomography (PET) imaging; limited area (eg, chest, head/neck)
78812	Positron emission tomography (PET) imaging; skull base to mid-thigh
78813	Positron emission tomography (PET) imaging; whole body
78814	Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; limited area (eg, chest, head/neck)
78815	Positron emission tomography (PET) with concurrently acquired CT; skull base to mid-thigh
78816	Positron emission tomography (PET) with concurrently acquired CT; whole body

Applicable HCPCS - PSMA radiotracers (covered when criteria met)HCPCSCovered

A9593	Gallium Ga-68 PSMA-11, diagnostic (UCSF) mCi
A9594	Gallium Ga-68 PSMA-11, diagnostic (UCLA) 1 mCi
A9595	mCi
A9596
A9608	Flotufolastat f18, diagnostic, millicurie
A9800	Gallium Ga-68 gozetotide, diagnostic (Locametz) 1 mCi

Provider Actions

Prior Authorization

Authorization required when criteria apply

PSMA PET/CT requires prior authorization when the policy criteria are met. Before submitting, use the Pre-authorization Code Check to verify authorization requirements for the specific code and plan type, as requirements may vary by plan.

Documentation Required

Conventional imaging prior to PSMA PET/CT

Conventional imaging (CT and/or bone scan) must have been performed within the last 2 months when required by the clinical criteria. Include the conventional imaging reports (CT and/or bone scan) in the documentation submitted to support the PSMA PET/CT request.

Documentation Required

Clinical notes submission

Submit the last 6 months of clinical notes from the requesting provider and/or specialist to support medical necessity for covered PSMA PET/CT indications.

Background & Evidence

Background: PSMA radiotracer PET/CT provides greater sensitivity for detecting and better characterizing early metastatic prostate cancer lesions compared with conventional imaging (CT, bone scan), and testing with these agents can change management by more frequently detecting metastatic disease. However, review panels concluded that although clinical validity is supported, the current body of evidence is of low to insufficient quality to demonstrate that PSMA imaging improves patient health outcomes, and continued monitoring of emerging evidence and therapeutics (for example, 177Lu‑PSMA radioligand therapy) is recommended.

Historically, Axumin (fluciclovine) PET was used for prostate cancer imaging, but this policy states that Axumin PET is no longer recommended for the covered indications. The Medical Policy Committee approved the PSMA PET/CT coverage criteria (with Axumin no longer recommended) requiring 60‑day notice, effective June 1, 2023, and later approved modified criteria effective June 1, 2025; the document also notes MTAC and INTC reviews and the need to monitor developments in PSMA imaging and PSMA‑targeted therapies.

Evidence

Definitions

Medicare Determinations

NCD Number / Name	Effective Date
220.6 Positron Emission Tomography (PET) Scans (General)
2022-01-01

Revision History

2023-01-09MPC approval (material)

MPC approved coverage criteria for PSMA (Pylarify, Gallium-68 and other FDA-approved PSMA tracers) PET/CT Imaging Guidelines for Prostate Cancer and specified that Axumin (fluciclovine) PET is no longer recommended; required 60-day notice with effective date June 01, 2023.

2023-03-03Codes/references update

Updated applicable codes to include A9800 (effective 10/01/2023) and updated references to include TheraP and VISION trials.

2025-01-14MPC approval (material)

Policy Summary

PayerKaiser Permanente

PolicyKaiser Permanente Clinical Review Criteria for PSMA PET/CT Imaging Guidelines for Prostate Cancer

Policy CodePolicy N/A

Change TypeCriteria added/modifiedcodes updated

Effective DateJun 1, 2023

Next Review Date

Key ActionInclude conventional imaging reports (CT and/or bone scan within last 2 months) and the last 6 months of clinical notes when submitting requests to support medical necessity.

SourceLink

On This Page

Conventional imaging (bone scan and CT) was completed within the last 2 months

Conventional imaging results are equivocal or indeterminate for metastatic disease

PSMA PET/CT can be considered if local salvage external beam radiotherapy (EBRT) is planned or being considered, provided widespread systemic disease is NOT present

Post-radiation serologic relapse (after primary radiotherapy)

PSA rise of >= 2 ng/mL above nadir on two separate occasions (Phoenix criteria)>= 2.0 ng/mL above nadir
Phoenix criteria
Conventional imaging with CT and/or bone scan performed within the last 2 monthswithin 2 months
PSMA PET/CT can be considered if salvage surgery or localized therapy is planned/considered and widespread systemic disease is NOT present

Lower PSA with rapid PSA doubling time and consideration of oligometastatic therapy

PSA >= 0.5 ng/mL and PSA doubling time (PSADT) approximately 2 to 3 months>= 0.5 ng/mL; PSADT ~2-3 months
PSADT most accurate for PSA > 1 ng/mL
Conventional imaging with CT and/or bone scan performed within the last 2 monthswithin 2 months
PSMA PET/CT can be considered if radiation oncology would recommend and patient would consider treatment of oligometastatic disease (generally <= 5 lesions) if confirmed<= 5 lesions

PSA >= 2.0 ng/mL with PSADT threshold

PSA >= 2.0 ng/mL and PSA doubling time 2 to 3 months>= 2.0 ng/mL; PSADT ~2-3 months
more rapid doubling time increases risk of systemic disease; PSADT most accurate > 1 ng/mL

Candidate for PSMA Lutetium (CRPC)

Patient is a definite candidate for PSMA Lutetium for castration-resistant prostate cancer (CRPC)
CRPC = progression despite castrate testosterone <50 ng/dL
PSMA PET/CT can be considered to determine suitability (refer to radiopharmaceuticals / Pluvicto criteria)

title": "Biochemical Recurrence and Treatment-Specific Re-staging

Not Covered - NCCN favorable-intermediate and lower-risk disease

PSMA PET/CT is not covered when patients meet these risk categories and do not fit other criteria above:

ALL of the following

NCCN favorable-intermediate and lower-risk disease (not fitting other criteria)

Denial Risk

Claims denied if surveillance/restaging requests don't meet criteria

Requests for surveillance or restaging with PSMA or Axumin PET/CT that do not meet the policy’s specified clinical criteria are considered not medically necessary and may be denied.

MPC approved modified criteria for PET PSMA for commercial members and applied modified criteria to Medicare reviews; required 60-day notice with effective date June 01, 2025.

2025-02-25Administrative clarification

Added link to retired PET scan NCD 220.6 and clarifying language that KPWA commercial policy may supplement the retired Medicare NCD for PSMA PET reviews.

2025-09-25Planned codes updateLatest

Entry in revision history noting an update to applicable codes (planned update dated 09/25/2025).