CurrentMass General Brigham Health PlanPolicy N/A

Prostate-Specific Membrane Antigen (PSMA) PET Imaging for Prostate Cancer

Defines medical necessity, authorization, and coverage criteria for PSMA-targeted PET imaging (specific radiotracers) in adult men with prostate cancer for initial staging, restaging/recurrence, and suspected progression; applies to Mass General Brigham Health Plan members and plan variations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyProstate-Specific Membrane Antigen (PSMA) PET Imaging for Prostate Cancer

Policy CodePolicy N/A

Change TypeRestaging criteria updatedPosluma added

Effective Date

Next Review Date

Key ActionObtain prior authorization for PET imaging CPT codes 78812-78816 where required.

SourceLink

POLICY UPDATE CHANGES

Updated prior authorization table and added variation for OneCare and SCO members.

Updated Restaging/Recurrent eligibility criteria per NCCN guidelines.

Added Posluma (flotufolastat F18) code and criteria.

3FDA-approved PSMA agents

3 monthsPET/CT exclusion interval

0.1 ng/mLPSA persistence threshold

78812-78816, A9593-A9800Procedure & supply codes

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Coverage Criteria for PSMA-Targeted PET Imaging

Initial staging / work-up

Covered when ANY one of the following initial staging conditions is met:

Initial staging / work-up: Unfavorable intermediate-risk disease; OR High-risk disease; OR Very high–risk disease; OR Inconclusive bone findings on both CT/MRI and bone scan; OR Conventional imaging (CT and bone scan) suggests minimal or low-volume metastatic disease that needs further evaluation.

Per policy initial work-up criteria

Restaging / Biochemical recurrence

Covered when ALL of the following for restaging/recurrence are met:

Restaging (recurrence of non-metastatic prostate cancer): Previously treated with prostatectomy or radiation therapy; AND one of the following biochemical findings: PSA persistence defined as detectable PSA (>= 0.1 ng/mL) at 3 months postoperatively; OR rising PSA on two or more occasions; OR PSA rises to at least 0.1 ng/mL if PSA was previously undetectable; AND the member is a candidate for salvage local therapy.PSA persistence >= 0.1 ng/mL at 3 months postoperatively

All elements required for restaging eligibility per policy

Suspected progression in treated metastatic disease

Covered when ALL of the following for suspected progression in previously treated metastatic prostate cancer are met:

Workup of suspected progression in previously treated metastatic disease: Previously treated with a novel hormone therapy (abiraterone, enzalutamide, darolutamide, or apalutamide); AND previously treated with docetaxel.

Both prior novel hormone therapy and prior docetaxel required per policy

Requests for PSMA PET imaging will be denied when a PET/CT has been performed within the past 3 months. Do not authorize repeat PSMA PET/CT imaging within a 3-month interval unless the clinical documentation clearly justifies an exception based on new, acute clinical change not addressed by the prior study.

For MassHealth plan variations, flotufolastat (Posluma) is considered not payable. Mass General Brigham Health Plan follows MassHealth guidance for its ACO members; where MassHealth has not issued separate guidance for the requested PSMA agents, the Plan’s medical policy applies, but flotufolastat is specifically noted as not payable under the MassHealth variation.

Procedure and Supply Codes

Covered/authorization-required PET CPT codesCPTCovered

78812	PET IMAGING SKULL BASE TO MID-THIGH
78813	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 computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid-thigh
78816	Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; whole body

Radiotracer HCPCS supply codesHCPCS

A9593	Gallium ga-68 psma-11, diagnostic, (ucsf) 1 millicurie
A9594	Gallium ga-68 psma-11, diagnostic, (ucsf) 1 millicurie
A9595	Piflufolastat f-18, diagnostic, 1 millicurie
A9596	Gallium Ga-68 gozetotide, diagnostic (Illuccix) 1 mCi
A9608	Flotufolastat f18, diagnostic, 1 millicurie
A9800	Gallium Ga-68 gozetotide, diagnostic (Locametz) 1 mCi

inv-08: PSA persistence threshold

PSA persistence threshold>= 0.1 ng/mL measured at 3 months after radical prostatectomy

Context in restaging criteriaOne of the required criteria for restaging/recurrence: previously treated with prostatectomy or radiation and PSA persistence ≥0.1 ng/mL at 3 months postoperatively

Alternate PSA patterns notedPolicy also accepts rising PSA on two or more occasions or PSA rising to ≥0.1 ng/mL if previously undetectable

inv-09: Detection rate reporting PSA bands

PSA reporting bands (detection rates)<0.5 ng/mL

PSA reporting bands (detection rates)0.5–1.0 ng/mL

Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Authorization is required for the listed PET imaging CPT codes for applicable commercial, Qualified Health Plans, and Medicare Advantage members. Submit prior authorization for PET imaging CPT codes 78812, 78813, 78814, 78815, and 78816 when requested for those product lines.

Authorization required: CPT 78812, 78813, 78814, 78815, 78816 (Commercial, Qualified Health Plans, Medicare Advantage)

Denial Risk

Recent PET/CT Exclusion

Requests for PSMA PET imaging may be denied if a PET/CT has been performed within the past 3 months. Verify prior imaging history and document timing to avoid denials.

Exclusion: PET/CT performed within prior 3 months

Background on PSMA-Targeted PET Imaging

PSMA-targeted PET imaging agents—such as piflufolastat F-18 (Pylarify), flotufolastat F-18 (Posluma), and Ga-68 PSMA-11—are FDA‑approved diagnostic radiotracers used to detect PSMA‑positive lesions in men with prostate cancer. These agents have greater sensitivity and specificity than conventional imaging for detecting pelvic nodal and distant metastases and are indicated for use in initial staging and in the evaluation of biochemical recurrence. Detection rates for these radiotracers correlate with PSA level, and the clinical evidence base (including pivotal trials for Ga‑68 PSMA‑11 and piflufolastat F‑18) supports their diagnostic utility in appropriately selected patients.

Definitions and Agent List

inv-16: PSMA-targeted PET agents

Included agents (examples)Piflufolastat F18 (Pylarify)

Included agents (examples)Flotufolastat F18 (Posluma)

Included agents (examples)Ga‑68 PSMA‑11 (Gozetotide)

inv-17: Biochemical recurrence (BCR)

DefinitionRecurrent prostate cancer after primary definitive treatment detected by rising PSA

Post-prostatectomy BCR threshold (trial/policy reference)PSA ≥ 0.2 ng/mL used in pivotal trials and summarized in evidence (CONDOR, VIA) as an entry criterion for biochemical recurrence detection

Post-radiotherapy BCR threshold (trial/policy reference)