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ModifiedKaiser PermanentePolicy N/A

Positron Emission Tomography (PET) Scan Clinical Review Criteria

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Clinical criteria governing medical necessity and use of PET scans for Kaiser Foundation Health Plan of Washington members, intended for providers and internal use to guide coverage decisions across oncologic and certain non-oncologic indications.

Policy Summary

PayerKaiser Permanente

PolicyPositron Emission Tomography (PET) Scan Clinical Review Criteria

Policy CodePolicy N/A

Change TypeOperational and clinical updates (radiopharmaceutical listings, tracer-specific criteria, MTAC conclusions)

Effective DateN/A

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization with supporting clinical and radiology documentation (last 6 months) and document expected change in clinical management for PET requests.

SourceLink

POLICY UPDATE CHANGES

Axumin (fluciclovine F-18, HCPCS A9588) PET is no longer recommended.

Listed covered radiopharmaceuticals for Medicare section per LCA A54668 and added Gallium Ga-68 PSMA-11 and Piflufolastat F-18 (PSMA PET for prostate) as currently not medically necessary for non-Medicare.

Added coverage for PET-PSMA with separate criteria and merged Positron Emission Mammography (PEM) criteria into the PET policy.

Added coverage criteria for Beta Amyloid PET for Alzheimer's evaluation.

Updated head and neck PET criteria to align with NCCN guidelines.

multipleOncologic indications listed

retiredRetired Medicare/local items

disease-specificStaging/restaging guidance

insufficientAlzheimer's PET evidence

A9588 removedAxumin recommendation

05/05/2026Last review date

Medical Necessity and Coverage Criteria

Solitary Pulmonary Nodule (No confirmed oncologic diagnosis)

PET for solitary pulmonary nodule (no oncologic diagnosis) is covered when ALL of the following are met:

SPN criteria: Newly discovered solitary pulmonary nodule in a person without a known prior malignancy; a concurrent thoracic CT has been performed; a single indeterminate or possibly malignant lesion > 0.8 cm in diameter has been detected; lesion is not a ground-glass opacity/nodule; the purpose of the PET is to determine the likelihood of malignancy to plan management of care> 0.8 cm

From Solitary Pulmonary Nodule section

General Oncologic Indication

For patients with a confirmed oncologic diagnosis, PET may be medically necessary when the following apply:

General oncologic requirement: Standard staging/restaging diagnostic and imaging studies are inconclusive AND further characterization is needed to make management decisions AND the expected change in clinical management is documented in the clinical records

Policy Summary

PayerKaiser Permanente

PolicyPositron Emission Tomography (PET) Scan Clinical Review Criteria

Policy CodePolicy N/A

Change TypeOperational and clinical updates (radiopharmaceutical listings, tracer-specific criteria, MTAC conclusions)

Effective DateN/A

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization with supporting clinical and radiology documentation (last 6 months) and document expected change in clinical management for PET requests.

SourceLink

On This Page

General rule for confirmed oncologic diagnosis

Breast Cancer

Breast cancer specific:

Breast PET indications: PET may be indicated when ONE of the following is met: (1) Stage III or IV disease for initial staging when conventional imaging is equivocal; OR (2) Exceptional cases with rationale provided by a tumor board of breast cancer expertsStage III or IV

PET is not first-line for breast cancer; not covered for Stage I-II, initial diagnosis, axillary nodal staging, routine surveillance, or routine monitoring

Head and Neck Cancer

Head and neck cancer specific:

Head & Neck staging: Staging indicated for locoregionally advanced disease (locoregionally advanced = T3 or T4 or ≥ N1) of specified head and neck sites; nasopharyngeal cancer may be appropriate for stage II if node positiveT3/T4 or >=N1

Restaging allowed for stage III-IV cancers after treatment (minimum 12 weeks); repeat PET not indicated for surveillance if initial post-treatment study is negative

Lung Cancer

Lung cancer specific:

NSCLC/SCLC indications: For non–small cell lung cancer (NSCLC) and limited‑stage small cell lung cancer (SCLC), PET is indicated for initial staging when active treatment is planned and to assist radiation therapy planning; recognize false positives from infection/inflammation and false negatives for small or low‑activity lesions

SCLC: indicated for limited‑stage (I–III) when active treatment is planned; PET not recommended for routine follow‑up in most cases

Lymphoma

Lymphoma:

Lymphoma indications: For Hodgkin disease and many intermediate/high‑grade non‑Hodgkin lymphomas PET is essential for initial staging; used for end‑of‑treatment restaging and sometimes for early/interim restaging (after 2–4 cycles) if a change in management is anticipated; surveillance is not recommended

Biopsy of PET‑positive sites should be considered; wait minimum intervals after therapy when specified

Prostate Cancer

Prostate cancer and specific radiotracers:

Prostate PET guidance: Axumin (18F‑fluciclovine) PET is no longer recommended by this policy; PSMA PET criteria are located separately and should be used for prostate imaging when applicable; PET use for prostate cancer must follow tracer‑specific criteria

Refer to PSMA PET criteria; Axumin shown to have high diagnostic performance for recurrence in studies but not recommended per MTAC assessment in this document segment

Thyroid Cancer

Thyroid cancer specific:

Thyroid localization: Localization PET for papillary or follicular thyroid carcinoma is covered when all of the following are met: previously treated with thyroidectomy and radioiodine ablation; thyroglobulin (TG) with TG‑antibody positive (stimulated or on suppression) > 10; and structural imaging (ultrasound and CT) is negative; also covered for aggressive histology or progressive metastatic disease on imaging or rising TG despite prior treatmentTG > 10

Used for localization when structural imaging is negative

Evidence-based coverage conclusions

Evidence-based conclusions and tracer-specific stances from MTAC reviews and internal assessments:

Alzheimer's disease / dementia (FDG PET): FDG PET does not meet Kaiser Permanente MTAC criteria for routine evaluation of Alzheimer's disease or dementia; available studies do not demonstrate that adding FDG PET to standard clinical evaluation improves diagnostic accuracy or outcomes

See MTAC reviews

Beta‑amyloid PET agents are covered only when the patient is a candidate for monoclonal antibody therapy and lumbar puncture is indeterminate or contraindicated (contraindications include bleeding risk, infection risk, anatomic abnormalities, prior failed lumbar puncture)

Policy delineates narrow coverage conditions

Emergent tracers (e.g., 18F‑NaF): There is insufficient evidence to show some emergent tracers are as safe/effective as standard services or provide better long‑term outcomes (example: 18F‑NaF PET for bone metastases)

Limited and small studies

Breast cancer (FDG PET): FDG PET for diagnosis, staging and restaging of breast cancer did not pass MTAC diagnostic test criteria due to limited sensitivity/specificity and insufficient evidence to replace biopsy or conventional imaging for many indications

MTAC evidence review summary

Breast cancer - Not supported by MTAC

Breast cancer - Diagnosis, staging, restaging

MTAC conclusion: FDG PET for diagnosis, staging and restaging of breast cancer did not pass the Kaiser Permanente Medical Technology Assessment Diagnostic Test Evaluation Criteria.

Evidence: limited studies; monitoring response studies exist but overall criteria not met.

Cervical cancer - Not supported by MTAC

Cervical cancer - Staging and re-staging

MTAC conclusion: Use of FDG‑PET in the diagnosis and management of cervical cancer does not meet the Kaiser Permanente Medical Technology Assessment Criteria due to insufficient evidence of therapeutic impact; biopsy remains standard in symptomatic patients and PET may be considered when conventional imaging is inconclusive

Histologic confirmation recommended before major treatment changes

Colorectal cancer - Mixed support

Colorectal cancer - Primary staging and recurrence

Primary staging: Evidence supporting FDG PET for primary staging of colorectal cancer in the absence of CT is weak; PET should not supplant contrast‑enhanced CT as first‑line staging

Small studies and methodological limitations

Recurrence/restaging: FDG PET has evidence supporting accuracy for identifying colorectal cancer recurrence and metastases and can influence surgical decision‑making, but there is no evidence demonstrating improved health outcomes such as survival

Use when conventional imaging is inconclusive or when CEA/LFTs remain elevated

Esophageal cancer - Limited for local staging; useful for distant disease

Esophageal cancer - Diagnosis, staging and restaging

Diagnosis/staging: FDG PET is not appropriate as a first‑line diagnostic procedure for esophageal cancer and does not reliably define local invasion or tumor depth; it is more sensitive for distant nodes and occult metastases but may both over‑ and under‑stage disease; positive PET findings should be verified histologically or radiologically before denying curative treatment

Limited studies; interpret positive findings cautiously

Restaging: FDG PET can be highly sensitive for symptomatic recurrent esophageal cancer in some studies but did not show statistically significant improvement over conventional procedures; false positives from inflammation are a concern

Limited evidence; cautious interpretation recommended

Head & neck cancer - Supported for staging in some studies; restaging uncertain

Head and neck cancer - Diagnosis, staging and restaging

Staging/lymph node assessment: Prospective studies (n>50) showed FDG PET had superior performance to other modalities for identifying lymph node metastases in head and neck cancer; evidence supports improved diagnostic performance for staging in some studies

Variation exists across studies; use in specified advanced disease stages

Restaging/recurrence: Evidence is insufficient to draw clear conclusions about FDG PET effectiveness for detecting recurrence of head and neck cancer; specificity was low in some studies and the diagnostic tool failed criterion 4 in MTAC review

Restaging role is less certain; consider timing post‑treatment

FES-PET - Not supported

FES-PET for estrogen receptor imaging in metastatic breast cancer

MTAC conclusion: Use of 18F‑fluoro‑estradiol PET (FES‑PET) to measure estrogen receptor expression in advanced breast cancer does not meet Kaiser Permanente MTAC criteria due to insufficient evidence from small studies; biopsy remains standard for ER assessment

Limited diagnostic accuracy data; small sample sizes

Indication-specific coverage conclusions

Summary of conclusions for specific indications in this document segment

Head and neck cancer (diagnosis, staging, restaging): Prospective studies exist but overall use of FDG PET as a diagnostic tool for head and neck cancers failed diagnostic efficacy criteria; evidence tables cite comparative studies

See evidence tables

Melanoma (staging and restaging): Evidence is inconclusive for diagnosis, staging, and restaging of melanoma; FDG PET may be useful for distant metastases but is not covered for regional lymph node evaluation

Sensitivity/specificity vary by study and stage

Prostate cancer — C‑11 acetate PET: C‑11 acetate PET has insufficient evidence to determine accuracy for diagnosis or monitoring of prostate cancer and does not meet MTAC criteria

Small studies only

Refractory seizures — pre‑surgical evaluation: FDG PET may help localize seizure focus for pre‑surgical evaluation but studies are small and methodologically limited; evidence failed criterion 2

Limited study sizes

Detection of bone metastases — 18F‑NaF and FDG PET: 18F‑NaF PET may be more sensitive than bone scintigraphy in some small studies but overall evidence is limited; 18F‑FDG PET and FDG PET/CT for bone metastases did not meet MTAC assessment criteria

Larger prospective studies needed

Prostate cancer — 18F‑fluciclovine (Axumin): Low‑quality evidence shows high clinical performance of fluciclovine PET in suspected prostate cancer recurrence and changes management, but Axumin was concluded to not meet MTAC criteria in this document segment

Six studies met inclusion criteria; policy states Axumin no longer recommended

General medical necessity

Considered Medically Necessary when criteria in the applicable policy statements listed above are met:

General: PET CPT/HCPCS codes and listed radiopharmaceuticals are considered medically necessary when the specific applicable policy clinical criteria are satisfied

See individual indication sections elsewhere in policy document for indication‑specific criteria

Medicare not covered items

Medicare distinctions

Medicare Not Covered: Certain PET uses and items are considered not covered for Medicare as listed in the policy (Medicare 'Considered not covered' entries); Non‑Medicare coverage follows the medically necessary criteria above

See Medicare section and policy history for specific not‑covered items and code distinctions

FDG PET is not covered for routine surveillance, initial diagnosis, or axillary nodal staging of breast cancer. The policy specifies PET is not a first‑line staging modality for breast cancer and may be considered only for Stage III or IV disease when conventional imaging is equivocal or when a tumor board provides a documented rationale. Requests for PET in Stage I–II disease, for initial diagnostic workup, for routine post‑treatment surveillance, or solely for axillary nodal staging may be denied.

PET is not indicated for lip and salivary gland cancers in the absence of advanced stage disease. For lip lesions and salivary tumors the policy directs that PET should not be used routinely unless disease is advanced (e.g., Stage III) and that CT or MRI are the preferred anatomic imaging modalities for salivary tumors.

Routine surveillance PET imaging is generally discouraged for several conditions. Surveillance PET is not recommended for most lymphoma follow-up (surveillance due to false positives), is not indicated for routine staging of Stage I–II melanoma unless specific signs or symptoms warrant imaging, and repeat PET is not indicated for surveillance if an initial post‑treatment study is negative. PET surveillance requests lacking clinical indications or evidence of management impact may be considered not medically necessary.

The evidence reviews concluded that routine use of FDG PET for the evaluation of Alzheimer’s disease or dementia does not meet the Medical Technology Assessment Criteria. Available studies do not demonstrate that adding FDG‑PET to standard clinical assessment improves diagnostic accuracy or patient outcomes, and therefore FDG PET for routine assessment of Alzheimer’s/dementia is not supported.

Several tumor‑specific MTAC conclusions state that FDG PET or FES‑PET does not meet Kaiser Permanente assessment criteria for routine diagnostic or treatment decision use. Examples include: FES‑PET for estrogen receptor imaging in advanced breast cancer, which failed MTAC criteria due to limited and small studies; FDG PET for breast cancer (diagnosis/staging/restaging) which did not pass diagnostic test evaluation criteria; and FDG PET in cervical and colorectal cancer where the evidence was judged insufficient to support routine diagnostic use.

FDG PET is not covered for regional lymph node evaluation in melanoma. Similarly, 18F‑FDG PET and 18F‑FDG PET/CT for detection of bone metastases were concluded to not meet assessment criteria in the evidence review. In prostate cancer, C‑11 acetate PET evidence was insufficient; and 18F‑fluciclovine (Axumin) PET was reviewed but was determined in this document segment to not meet MTAC criteria.

The MTAC evidence reviews in this policy determined that use of certain newer or site‑specific tracers did not meet assessment criteria. Specifically, Axumin (18F‑fluciclovine) PET, florbetapir (Amyvid) PET for Alzheimer’s disease, and Positron Emission Mammography (PEM) were each judged by MTAC reviews to lack sufficient evidence to meet the Medical Technology Assessment Criteria and therefore are not supported as routine services in this policy.

The policy reiterates that routine PET surveillance for breast cancer is not medically necessary. PET is not a first‑line modality for breast cancer staging; it may only be considered in Stage III or IV when conventional imaging is equivocal or in exceptional, documented tumor‑board cases. Routine monitoring or surveillance PET in early‑stage disease or after treatment without clinical concern is not supported.

Routine PET for early‑stage melanoma (Stage I–II) for staging or surveillance is not medically necessary unless specific signs or symptoms indicate further evaluation. PET is reserved for Stage III–IV disease for baseline staging or to address clinical concerns; CT or MRI may be used when appropriate.

The addition of FDG‑PET to standard clinical evaluation for Alzheimer’s disease/dementia did not meet MTAC criteria in prior reviews. As a result, the policy states that FDG PET for routine diagnostic evaluation in Alzheimer’s/dementia is not supported by the evidence and is not covered as standard care.

Routine diagnostic use of FDG PET for primary diagnosis across several tumor sites is not supported by MTAC findings. FDG PET as a primary diagnostic tool failed MTAC diagnostic efficacy criteria for colon cancer and for head and neck cancers (failed criterion 4), and FDG‑based approaches for primary breast cancer diagnosis likewise did not meet MTAC criteria; biopsy and conventional imaging remain standard diagnostic approaches.

C‑11 acetate PET for prostate cancer and 18F‑FDG PET/CT for evaluation of bone metastases were found to have insufficient evidence to meet assessment criteria. The C‑11 acetate evidence base included very small studies without adequate comparison to gold standards, and 18F‑FDG PET for bone metastases lacked sufficient high‑quality data to support routine use; similarly, 18F‑NaF and other bone tracers require more evidence.

Specific tracer determinations in the MTAC reviews led to conclusions that Axumin (fluciclovine F‑18), florbetapir (Amyvid) for Alzheimer’s disease, and Positron Emission Mammography (PEM) did not meet Medical Technology Assessment Criteria in the evidence reviews cited. Operational updates in the policy removed Axumin from the recommended radiopharmaceutical list and archived/merged PEM into the PET policy section.

Indications Considered Covered / Appropriate Use

Solitary pulmonary nodule evaluation (no confirmed oncologic diagnosis) — covered indication node

SPN covered indication: Concurrent thoracic CT performed AND single indeterminate lesion > 0.8 cm AND lesion is not a ground‑glass opacity AND the purpose is to determine likelihood of malignancy to plan management> 0.8 cm

From Solitary Pulmonary Nodule evaluation

Thyroid cancer localization when structural imaging negative — covered indication node

Thyroid localization covered indication: Previously treated with thyroidectomy and radioiodine ablation AND TG‑antibody positive with TG > 10 (stimulated or on suppression) AND negative structural imaging (ultrasound and CT)TG > 10

Localization when structural imaging negative

Lymphoma staging and response assessment — covered indication node

Lymphoma covered indication: Hodgkin disease and many intermediate/high‑grade non‑Hodgkin lymphomas: initial staging is essential; end‑of‑treatment restaging and interim restaging after 2–4 cycles may be used if a change in management is anticipated; surveillance not recommended

Biopsy of PET‑positive sites should be considered; timing (wait minimum intervals) applies

Appropriate-use statements and indications — aggregate of common appropriate uses

Appropriate use aggregate: PET has demonstrated utility across multiple malignancies (lung, colon, lymphoma, melanoma, selected uses in breast and prostate) for staging, restaging, and monitoring, though evidence strength varies by tumor type and indication; requests are subject to Medical Director review and a request log is maintained

See individual sections for indication‑specific criteria

Colorectal cancer — suspected recurrence/restaging — covered indication node

Colorectal recurrence covered indication: FDG PET may be used to evaluate suspected colorectal cancer recurrence or metastases (e.g., when CEA/LFTs remain elevated and conventional imaging is negative) and to assess potentially resectable metastatic lesions to confirm absence of other disease; consider histologic confirmation for management changes

Evidence supports PET accuracy for recurrence though no demonstrated survival benefit

Esophageal cancer — detection of distant metastases or occult metastatic disease — covered indication node

Esophageal distant disease covered indication: FDG PET may be used to detect distant nodal and occult organ metastases in esophageal cancer when CT chest/abdomen shows no metastases and the individual is a candidate for aggressive therapy; PET is not appropriate for local T‑stage assessment

Positive PET findings should be verified before denying curative treatment

Head and neck cancer — nodal staging — covered indication node

Head & neck nodal staging covered indication: FDG PET may be used for nodal staging in head and neck cancers in select patients (prospective studies showed superior performance for lymph node metastases detection); use for staging in locoregionally advanced disease is supported

Restaging utility is less certain and failed certain MTAC diagnostic criteria

Cervical cancer — evaluation of suspected recurrence — covered indication node

Cervical recurrence covered indication: For suspected cervical cancer recurrence, PET may be considered when conventional imaging (CT/MRI) is inconclusive; biopsy remains routine for symptomatic patients and histologic confirmation is recommended prior to major treatment changes

MTAC concluded PET evidence insufficient for routine diagnosis

Imaging indications evaluated in document section — summary of multiple indications

Imaging indications summary: This policy evaluated multiple indications including head & neck, melanoma, prostate recurrence (fluciclovine), bone metastases (18F‑NaF), refractory seizures, and others; conclusions vary by indication with several failing MTAC criteria and others supported for discrete uses

Refer to per‑tumor sections for details

Alzheimer's disease / amyloid imaging — criteria for beta-amyloid PET (narrow coverage)

Amyloid PET agents (e.g., florbetapir A9586, flutemetamol Q9982) are discussed; FDG PET and amyloid imaging do not meet MTAC criteria for routine use in Alzheimer's disease, and specific narrow coverage criteria apply for beta‑amyloid PET when patient is candidate for monoclonal antibody therapy and lumbar puncture is indeterminate or contraindicated

See beta‑amyloid PET criteria and contraindications to lumbar puncture

Prostate cancer recurrent disease imaging — PSMA and tracer‑specific coverage notes

Prostate recurrence PET: PET with fluciclovine tracer showed high clinical performance for suspected prostate cancer recurrence in low‑quality studies and influenced management; however, Axumin (A9588) is no longer recommended in this policy and PSMA PET criteria are addressed separately (Ga‑68 PSMA‑11, piflufolastat F‑18 referenced)

Refer to separate PSMA PET criteria and policy history re: Axumin removal

Services and Uses Considered Not Medically Necessary

PET for routine surveillance, initial diagnosis, or axillary lymph node staging in breast cancer is explicitly not covered. The document states PET is not covered for Stage I–II disease, for initial diagnosis, for axillary nodal staging, or for routine post‑treatment monitoring — authorization requests in these settings should include clear justification and may be denied.

Routine FDG PET for the diagnostic evaluation of Alzheimer’s disease/dementia and certain newer tracers (including amyloid agents in many contexts) is not supported for routine coverage. Prior MTAC reviews concluded there is insufficient evidence that FDG PET or florbetapir PET improves diagnostic accuracy or patient outcomes for typical Alzheimer’s/dementia evaluation, so routine requests may be considered not covered.

FDG PET is not covered for regional lymph node evaluation in melanoma. The policy also concludes that 18F‑FDG PET and 18F‑FDG PET/CT for the detection of bone metastases do not meet Medical Technology Assessment Criteria and therefore are not supported for routine use in that indication.

FDG PET for primary diagnosis and routine staging of breast cancer did not pass MTAC diagnostic test evaluation criteria; this MTAC failure is cited as a reason routine FDG PET for breast cancer diagnosis is not supported.

The breast cancer evidence review identified limited prospective studies and variable diagnostic performance; FDG PET did not meet the MTAC criteria for routine diagnostic or staging use in breast cancer.

MTAC appraisal of FDG PET in breast cancer showed insufficient evidence for routine use in diagnosis, staging, and restaging; management‑changing evidence and improved outcomes were not demonstrated in the reviewed studies.

Prospective evidence in breast cancer included axillary staging studies, response monitoring reports, and restaging series, but the collective evidence did not meet MTAC diagnostic efficacy criteria for routine clinical coverage.

The MTAC conclusion for breast cancer emphasized study limitations and insufficient evidence to replace standard diagnostic pathways; as a result FDG PET is not recommended as routine diagnostic imaging for breast cancer.

Because FDG PET for breast cancer failed MTAC diagnostic evaluation criteria, routine application for primary diagnosis or routine staging is not supported and may be denied absent compelling justification.

Billing Codes and Radiopharmaceuticals

No explicit CPT/ICD codes in this document segmentmixed

No codes listed

Covered CPT CodesCPTCovered

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 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.
78608	Brain imaging, positron emission tomography (PET); metabolic evaluation.
78609	Brain imaging, positron emission tomography (PET); perfusion evaluation.
78429	Myocardial imaging, positron emission tomography (PET), metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), single study; with concurrently acquired computed tomography transmission scan.
78459	Myocardial imaging, positron emission tomography (PET), metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), single study.

1–10 of 17

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Covered HCPCS Radiopharmaceuticals (listed)HCPCSCovered

A9586	Florbetapir F18, diagnostic, per study dose, up to 10 mCi.
A9587	Gallium Ga-68, dotatate, diagnostic, 0.1 mCi.
A9515	Choline C-11, diagnostic, per study dose up to 20 mCi.
A9592	Copper Cu-64, dotatate, diagnostic, 1 mCi.
A9593	Gallium Ga-68 PSMA-11, diagnostic, (UCSF), 1 mCi.
A9594	Gallium Ga-68 PSMA-11, diagnostic, (UCLA), 1 mCi.
A9595	Piflufolastat F-18, diagnostic, 1 mCi.
A9598	Positron emission tomography radiopharmaceutical, diagnostic, for nontumor identification, not otherwise classified.
A9601	Flortaucipir F18 injection, diagnostic, 1 mCi.
Q9982	Flutemetamol F18, diagnostic, per study dose, up to 5 mCi.

No longer recommendedHCPCSNot Covered

A9588

Fluciclovine F-18 (Axumin), diagnostic, 1 mCi.

Medicare-specific HCPCSHCPCS

G0235	PET imaging, any site, not otherwise specified.
G0252	PET imaging, full and partial-ring PET scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer.
G0219	PET imaging whole body; melanoma for noncovered indications.

SPN size threshold — solitary pulmonary nodule

SPN size threshold> 0.8 cm (single indeterminate or possibly malignant lesion)

Concurrent imaging requirementConcurrent thoracic CT must have been performed

Lesion morphology exclusionNot recommended for ground-glass opacities/nodules

Thyroglobulin threshold — differentiated thyroid carcinoma localization

Thyroglobulin (TG) thresholdThyroglobulin > 10 (TG-antibody positive; stimulated or on suppression)

Prior treatment requirementPreviously treated with thyroidectomy and radioiodine ablation

Imaging requirementNegative structural imaging (ultrasound and CT) required

Study sample size threshold — evidence strength commentary

Typical study sizes in reviewsMany cited studies had sample sizes <50; several evidence sections noted small case series

Methodology threshold notedStronger methodology defined by prospective design, blinded reads, quantified PET, and sample sizes >30

Implication for evidence strengthSmall sample sizes and methodological limitations reduce confidence in effectiveness conclusions

Radiopharmaceutical per-study dose limits — HCPCS descriptions

Florbetapir (A9586)Florbetapir F18, diagnostic, per study dose, up to 10 mCi

Flutemetamol (Q9982)Flutemetamol F18, diagnostic, per study dose, up to 5 mCi

Choline C-11 (A9515)Choline C-11, diagnostic, per study dose up to 20 mCi

Other listed radiopharmaceuticalsHCPCS list includes Cu-64 dotatate, Ga-68 dotatate, PSMA agents, piflufolastat, flortaucipir, and miscellaneous PET radiopharmaceutical codes with per-study dose descriptions

Prior Authorization, Documentation, and Operational Guidance

Prior Authorization

Prior authorization guidance — clinical review criteria apply

Clinical review criteria apply for medical necessity determinations; providers should verify member benefits via the member's Evidence of Coverage or Member Services and submit requests consistent with the clinical criteria in this policy.

Consult the patient's Evidence of Coverage or call Member Services to determine coverage specifics before ordering.
Medical necessity determinations are made per the Clinical Review Criteria included in this policy.

Prior Authorization

Medical Director review / utilization oversight required for select requests

Requests for PET in certain indications and for repeat studies (e.g., treatment monitoring sooner than specified intervals) require review by the Kaiser Permanente Medical Director of Radiology; utilization oversight includes maintaining a request log with determination outcomes.

Requests for PET performed more frequently than specified (e.g., cardiac sarcoidosis monitoring <3 months) require Medical Director review.
A request log with determination outcomes is maintained as part of utilization oversight.

Prior Authorization

Prior authorization considerations for colorectal PET uses

FDG PET for colorectal cancer has mixed evidence: primary staging evidence is weak while PET can identify recurrence and influence surgical decisions; therefore prior authorization should be considered when PET is requested for primary staging or recurrence evaluation.

Primary staging with FDG PET alone is not recommended because supporting evidence is weak.
PET may be used for suspected recurrence/restaging when conventional imaging is inconclusive, but consider prior authorization due to mixed evidence and lack of demonstrated survival benefit.

Prior Authorization

Prior authorization for tracers/indications not meeting MTAC

Several tracers and specific PET indications were judged to not meet MTAC criteria (e.g., FDG PET for bone metastases, Axumin noted as not meeting criteria in this segment); such tracer/indication combinations may require prior authorization and payer review.

Axumin (fluciclovine) is addressed in evidence reviews and later removed from recommended radiopharmaceutical list (see tracer-specific actions).
Emergent tracers (e.g., 18F-NaF) and some PET indications have insufficient evidence and may be subject to prior authorization.

Prior Authorization

Prior authorization required; Medicare distinctions apply

Prior authorization and appropriate supporting documentation are required when requesting PET studies or radiopharmaceuticals; Medicare-specific distinctions and not-covered designations apply per policy.

Submit required clinical and radiology documentation (see documentation callouts).
Be aware of Medicare-specific 'considered not covered' listings and HCPCS distinctions when requesting services for Medicare members.

Step Therapy

Radiopharmaceutical pathway — Axumin removed; see PSMA PET criteria

Operational policy change: Axumin (fluciclovine F-18) is no longer recommended as a radiopharmaceutical pathway option; refer to separate PSMA PET criteria for prostate imaging and alternative radiopharmaceutical guidance.

Axumin is explicitly stated as no longer recommended in the radiopharmaceutical list.
PSMA PET criteria are located separately for prostate imaging and should be used where applicable.

Step Therapy

Tracer‑specific prior considerations and narrow coverage for select tracers

Some PET tracers (for example, beta‑amyloid PET agents) are covered only in narrow circumstances — e.g., when the patient is a candidate for monoclonal antibody therapy and lumbar puncture is indeterminate or contraindicated — otherwise evidence is insufficient.

Beta‑amyloid PET is covered only when the patient is a candidate for monoclonal antibody therapy and lumbar puncture is indeterminate or contraindicated (contraindications listed in policy).
Emergent tracers like 18F‑NaF have insufficient evidence to support general use.

Step Therapy

Preferred sequence for cervical recurrence evaluation — CT/MRI and biopsy first

For suspected cervical cancer recurrence, CT or MRI and biopsy remain first‑line evaluations; PET may be considered when conventional imaging is inconclusive but histologic confirmation is routine in symptomatic patients.

CT/MRI and CT‑guided biopsy are commonly used first‑line to confirm recurrence.
PET can be used as an adjunct when conventional imaging is inconclusive, but biopsy remains the standard in symptomatic patients.

Note

No other specified provider actions in this segment

No additional provider actions specified in this portion of the document.

This document segment does not list further step therapy sequencing requirements beyond tracer-specific notes above.

Step Therapy

Therapeutic sequencing / tracer selection — Axumin removed

Axumin (HCPCS A9588) has been removed from the recommended radiopharmaceuticals list; providers should select alternative tracers consistent with policy and applicable PSMA PET criteria for prostate imaging.

A9588 (fluciclovine F‑18, Axumin) is listed as no longer recommended.
PSMA PET agents (A9593/A9594/A9595) are listed elsewhere with separate criteria for use in prostate cancer.

Documentation Required

Document expected management impact when used for staging/restaging

When PET is used for staging or restaging in a confirmed oncologic diagnosis, the expected change in clinical management must be documented in the clinical records supporting the request.

Document how PET results will affect management decisions (e.g., surgical plan, systemic therapy, radiation planning) in the clinical record.

Documentation Required

Required supporting documentation — last 6 months of clinical and radiology notes

Requests for PET services must include the last 6 months of clinical notes from the requesting provider/specialist and the last 6 months of radiology notes when applicable to support medical necessity.

Attach the last 6 months of clinical documentation from the requesting clinician/specialist.
Include relevant radiology reports from the last 6 months if available.

Documentation Required

Preferred confirmatory testing — biopsy standard; PET adjunct when imaging inconclusive

Biopsy is routinely performed in symptomatic patients to confirm cervical cancer recurrence; PET is an alternative only when conventional imaging is inconclusive and histologic confirmation remains standard.

Clinical practice favors CT/MRI and CT‑directed biopsy for histologic confirmation of recurrence in symptomatic patients.
Consider PET only when conventional imaging is inconclusive; obtain histologic confirmation before major management changes when feasible.

Documentation Required

Verify positive PET findings before denying curative therapy

Positive PET findings that would lead to denial of resection or curative therapy should be verified by histology or radiologic confirmation before proceeding to deny curative treatment.

Verify PET-positive findings (especially suggesting unresectable disease) histologically or with corroborative radiologic evidence prior to denying curative interventions.
Use caution interpreting PET results subject to false positives (e.g., inflammation).

Documentation Required

Supporting documentation — evidence tables and study details expected

Evidence tables and study details supporting each indication are referenced in the policy and should be available for review upon request to support clinical conclusions.

Evidence tables (MTAC reviews) and cited studies underlie the policy conclusions and should be provided if needed for appeals or medical review.
Maintain supporting literature and study details accompanying authorization requests when relevant.

Billing Rule

Document CPT/HCPCS code and indication consistent with policy

Providers must document the CPT/HCPCS code and specific clinical indication consistent with the applicable policy statement when requesting PET services to support medical necessity determinations.

Include the intended CPT/HCPCS procedure code and the clinical indication on the authorization request.
Ensure coding and indication align with the specific coverage criteria in this policy.

Denial Risk

SPN PET denial triggers — lesion size, CT requirement, ground‑glass nodules

PET for solitary pulmonary nodules will be denied if the lesion is a ground‑glass opacity/nodule or if the single indeterminate lesion is ≤0.8 cm or if a concurrent thoracic CT has not been performed.

Single indeterminate lesion must be >0.8 cm in diameter to meet SPN PET criteria.
A concurrent thoracic CT must have been performed and ground‑glass opacities/nodules are not recommended for PET evaluation.

Denial Risk

Breast cancer denial risk — early stage, initial diagnosis, axillary staging, surveillance

PET for breast cancer is not covered for Stage I–II disease, for initial diagnosis, for axillary lymph node staging, or for routine surveillance/monitoring; requests in these settings are likely to be denied.

PET may be considered for initial staging only in Stage III–IV disease or in exceptional cases with tumor board rationale.
Routine use for Stage I–II, axillary nodal staging, initial diagnosis, or surveillance is not covered.

Note

Denial Risk

Breast cancer — MTAC evidence failure may lead to denial

Use of FDG PET for diagnosis, staging, or restaging of breast cancer did not pass the MTAC diagnostic test evaluation criteria and may be denied absent the narrow indications described in policy.

MTAC review concluded FDG PET for breast cancer did not meet diagnostic test criteria.
Authorization should be supported by policy‑allowed criteria (e.g., Stage III/IV or tumor board justification).

Denial Risk

Cervical cancer — MTAC failure and restricted use

Use of FDG‑PET in the diagnosis of cervical cancer does not meet MTAC criteria and may be denied; PET may be considered as an adjunct for pre‑treatment evaluation of locally advanced disease to detect metastases when conventional imaging is equivocal.

MTAC concluded FDG‑PET does not meet Kaiser Permanente Medical Technology Assessment Criteria for cervical cancer diagnosis.
FDG‑PET may be reasonable for detecting metastases in newly diagnosed, locally advanced cervical cancer if conventional imaging is negative for extra‑pelvic disease.

Denial Risk

Colorectal cancer — MTAC evidence limitations and denial risk for primary diagnosis

Use of FDG PET as a diagnostic tool for colon cancer (primary diagnosis/staging) does not meet MTAC criteria and may be denied; PET has better accuracy for recurrence but lacks evidence of improved health outcomes.

Primary staging evidence is weak — FDG PET is not recommended as the sole first‑line modality for primary colorectal staging.
PET can be accurate for detecting recurrence and may influence surgical decisions, but prior authorization may be required given mixed evidence.

Denial Risk

Head & neck PET — MTAC failure for diagnostic use; selective indications only

FDG PET as a diagnostic tool for head and neck cancers failed MTAC diagnostic evidence criterion 4 and may be denied for routine diagnostic use despite some prospective studies showing improved nodal detection.

Some prospective studies (n>50) showed improved lymph node detection, but overall MTAC criteria for diagnostic efficacy were not met.
Restaging and routine diagnostic use remain uncertain and subject to denial absent policy‑specified indications.

Denial Risk

Potential denial triggers — melanoma, prostate (C‑11), bone mets, Axumin

Potential denial triggers include use of FDG PET for regional lymph node evaluation in melanoma (not covered), use of C‑11 acetate PET for prostate cancer (does not meet MTAC criteria), FDG PET/CT for bone metastases (does not meet criteria), and use of Axumin which does not meet MTAC criteria in this segment.

FDG PET is not covered for regional lymph node evaluation in melanoma.
C‑11 acetate PET for prostate cancer lacks sufficient evidence and does not meet MTAC criteria.
FDG PET and FDG PET/CT for bone metastases do not meet MTAC criteria.
Axumin Injection for PET Scan did not meet MTAC criteria in the reviewed evidence.

Denial Risk

Medicare coverage distinctions — some PET uses considered not covered

For Medicare members, certain PET uses and items are listed as 'considered not covered' in the policy; providers should review Medicare‑specific not‑covered designations before ordering.

Medicare section lists specific HCPCS/CPT items that are considered not covered for Medicare.
Non‑Medicare coverage may differ; verify payer‑specific rules.

Prior Authorization Requirements

Prior Authorization

Prior authorization — apply Clinical Review Criteria and Medicare guidance

Medical necessity determinations for PET require application of the Clinical Review Criteria; Medicare guidance and local coverage considerations are referenced and should be followed when applicable.

Documentation Required

Prior authorization documentation — Medical Director review and last 6 months of notes required

Requests for PET require Medical Director review for certain indications and must include supporting clinical and radiology documentation from the last 6 months to demonstrate medical necessity.

Prior Authorization

Prior authorization for colorectal PET uses — evidence mixed; may affect surgery

Use of PET for colorectal primary staging or suspected recurrence may require prior authorization because evidence is mixed and findings can influence surgical decision‑making.

Prior Authorization

Prior authorization note — tracers/uses that failed MTAC may need authorization

Some tracers and clinical uses failed MTAC assessment criteria (e.g., Axumin, FDG for certain indications); these may necessitate prior authorization review before approval.

Prior Authorization

Prior authorization requirement — radiopharmaceuticals and Medicare exclusions

Payer rules require prior authorization for certain radiopharmaceuticals and PET studies; Medicare exclusions and distinctions apply and are listed in the policy.

Repeat Imaging and Frequency Guidance

PET/CT frequency — surveillance after treatment

Surveillance after negative post-treatment PETIf initial post-treatment PET study is negative, repeat PET is not indicated for surveillance

Restaging timing for head & neckPost-treatment PET restaging should be performed a minimum of 12 weeks after radiation completion

When to repeat PETRepeat PET indicated at 3–6 months when initial post-treatment study is equivocal (per head & neck guidance)

PET frequency — cardiac sarcoidosis monitoring

Cardiac sarcoidosis monitoring intervalNot more frequent than every 3 months for treatment monitoring without Kaiser Permanente Medical Director review

Exception processRequests for intervals shorter than 3 months require Medical Director review

Modality referencedApplies to PET myocardial perfusion/treatment monitoring contexts (N-13 ammonia or Rb-82 perfusion referenced)

PET/CT frequency — additional guidance

Additional frequency guidance(No additional frequency guidance specified in this document segment)

Local reviewWhere frequency limits are unspecified, Medical Director review and prior authorization may be required per local payer rules

DocumentationProvide clinical rationale and prior imaging when requesting repeat studies outside routine intervals

Terms and Tracer Definitions

TNM definition

T (Tumor)T = tumor size and extent

N (Nodes)N = regional lymph node involvement

M (Metastasis)M = presence of distant metastasis

FDG PET definition

FDG PET (definition)PET imaging using 18F-fluorodeoxyglucose to evaluate regional glucose metabolism and detect altered metabolic activity in tumors and certain brain disorders

Clinical usesUsed to detect increased glucose uptake in malignancies and evaluate neurologic conditions such as seizures

MechanismFDG competes with glucose for cellular uptake and is trapped intracellularly, enabling metabolic imaging

PET definition — positron emission tomography

PET (general definition)A tomographic nuclear medicine procedure producing cross-sectional images by detecting radioactivity from injected radiopharmaceuticals to assess perfusion and metabolic activity

Imaging outputProduces functional images that complement anatomic imaging from CT/MRI

Common useApplied across oncology, neurology, and cardiology indications

FDG definition — 18F-fluorodeoxyglucose tracer

FDG tracer (18F-fluorodeoxyglucose)18F-fluorodeoxyglucose, a glucose analogue used as a PET tracer to image increased glucose metabolism in tumor cells

Imaging rationaleTumor cells often have higher glycolytic rates leading to elevated FDG uptake compared to benign tissue

Regulatory noteFDG PET has FDA approvals for certain indications (e.g., seizures) and expanded approvals noted in background sections

FES-PET definition — 18F-fluoro-estradiol tracer

FES-PET tracer18F-fluoro-estradiol PET (FES-PET) is a tracer proposed to image estrogen receptor expression in breast cancer metastases

Clinical contextIntended as a noninvasive alternative to biopsy for assessing ER heterogeneity in metastatic disease

Evidence statusMTAC review found insufficient evidence (small studies) and it does not meet assessment criteria in this document segment

FDG (18F-fluorodeoxyglucose) — tracer summary

FDG (summary)A PET radiotracer that images glucose metabolism; tumor cells often have increased FDG uptake compared to benign tissue

Primary applicationsUsed widely for oncologic staging, restaging, and select neurologic/cardiac indications

LimitationsFalse positives (inflammation/infection) and false negatives (small or low-activity lesions) can occur

C-11 acetate — prostate tracer definition and production notes

C-11 acetate (prostate tracer)C-11 acetate proposed for prostate cancer imaging; short half-life (~20 minutes) requires on-site cyclotron production

Clinical rationaleC-11 acetate may better reflect prostate tumor biology than FDG in slow-growing tumors

Operational limitationLimited to centers with an on-site cyclotron due to short half-life

18F-NaF (sodium fluoride) — PET bone tracer

18F-NaF (sodium fluoride)18F-NaF is a PET bone tracer reflecting bone metabolic activity and may detect lytic bone metastases not seen on 99mTc bone scan

Uptake specificityIncreased uptake is not tumor-specific and may reflect degenerative or benign bone disease

Evidence statusLimited evidence with small studies/meta-analysis; use did not meet MTAC criteria for routine bone metastasis evaluation in this document

18F-fluciclovine (Axumin) — tracer definition

18F-fluciclovine (Axumin)An amino-acid PET radiotracer used to detect recurrent prostate cancer by visualizing increased amino acid transport

Clinical performanceLow-quality evidence shows high diagnostic performance for suspected recurrence and influence on management

Policy statusDespite performance, Axumin (A9588) was concluded in this segment to not meet MTAC criteria and is no longer recommended per operational changes

Axumin (fluciclovine F-18) — short label

Axumin short labelFluciclovine (Axumin)

Primary indicationUsed for detection of recurrent prostate cancer after prior treatment

Policy noteHCPCS A9588 listed but removed from recommended radiopharmaceuticals in this document (operational change)

Florbetapir (Amyvid) — amyloid-beta PET tracer definition

Florbetapir (Amyvid)Florbetapir F-18 (Amyvid) is an amyloid-beta PET tracer for imaging brain amyloid plaques; FDA-approved for imaging but evidence is insufficient to show net health outcome benefits for AD diagnosis/management

Dose HCPCSListed HCPCS description: A9586 — per study dose up to 10 mCi (see radiopharmaceutical list)

Clinical limitationA positive scan does not establish a diagnosis of Alzheimer's disease and it does not replace other diagnostic tests

CT/Contrast and Modality Notes

Billing Rule

Contrast administration rules — none specified

No explicit contrast administration rules are provided in this segment of the policy.

Billing Rule

PET+CT coding guidance — use PET+CT CPT codes when CT acquired concurrently

When PET is performed with concurrently acquired CT for attenuation correction and anatomical localization, use the corresponding PET+CT CPT codes (for example 78814–78816) as listed in the policy.

Background and Scope

Positron emission tomography (commonly FDG PET/CT and disease‑specific radiotracers) is used to stage, restage, and assist treatment planning across multiple malignancies. PET can detect altered tumor metabolism, help localize occult disease when structural imaging is inconclusive, and contribute to radiation therapy planning; however, false positives (e.g., inflammation/infection) and false negatives (e.g., small lesions or low metabolic activity) are important limitations to consider when interpreting results.

Quick Reference Metrics

>0.8 cmSPN size threshold required for PET

6 monthsDuration of clinical/radiology documentation requested for prior auth

A9588Radiopharmaceutical removed from recommendation (Axumin)

~30Approx. CPT/HCPCS codes listed for PET and radiopharmaceuticals

05/05/2026Last policy review date

Policy Revision History and Changes

06/01/2021operational update

MPC endorsed SSR‑PET for neuroendocrine tumors and made site/service administrative updates; 60‑day notice with effective date 11/01/2021.

01/07/2022radiopharmaceutical listing change

Listed covered radiopharmaceuticals for Medicare per LCA A54668 and added Gallium Ga‑68 PSMA‑11 and Piflufolastat F‑18 (PSMA PET) as currently not medically necessary for non‑Medicare.

01/10/2023addition

MPC approved adoption of coverage for PET‑PSMA with notice; PSMA PET criteria located in separate criteria set (60‑day notice, effective June 1, 2023).

02/13/2024clinical criteria revision

MPC approved revision of clinical criteria for staging of breast cancer (60‑day notice, effective July 1, 2024).

05/06/2025operational removal/merger

MPC approved archiving of Positron Emission Mammography (PEM) criteria, effective May 20, 2025; PEM criteria merged into the PET policy.

07/01/2025clinical update

MPC approved updates clarifying and expanding PET use for cervical and uterine cancers (60‑day notice, effective 12/01/2025).

09/02/2025addition

MPC approved inclusion of coverage criteria for Beta Amyloid PET for Alzheimer's evaluation (60‑day notice, effective 02/01/2026).

05/05/2026clinical alignmentLatest

MPC approved updates to head and neck PET criteria to align with NCCN guidelines; 60‑day notice required with planned effective date 10/01/2026.

Last review date: 2026-05-05. The policy includes multiple operational changes identified as material, including removal of Axumin from recommended radiopharmaceuticals and additions/clarifications to tracer listings and Medicare distinctions; the document notes these updates and flags has_material_change: true in the policy history.