ModifiedUnitedHealthcarePolicy CS146ID.C

Electric Tumor Treatment Field Therapy (for Idaho Only)

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This policy governs coverage of FDA-approved electric tumor treatment field devices for newly diagnosed or recurrent supratentorial glioblastoma. It applies only to Idaho, including Idaho Medicaid Plus plans.

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ModifiedUnitedHealthcarePolicy CS146ID.C

Electric Tumor Treatment Field Therapy (for Idaho Only)

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Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Idaho Only)

Policy CodePolicy CS146ID.C

Change TypeModified

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionSubmit the clinical request with documentation supporting the applicable initial or continuation criteria.

SourceLink

POLICY UPDATE CHANGES

The policy adds notation that HCPCS code E0767 is not listed on the State of Idaho Medicaid Fee Schedule and therefore may not be covered by the Idaho Medicaid Program.

The clinical evidence and reference sections were updated to reflect current information.

Idaho onlyGeographic scope

3 monthsInitial approval period

≥18 hr/dayRequired device wear

KPS ≥60 or ECOG ≤2Performance status

≤2 monthsContinuation MRI timing

3 HCPCSApplicable code references

Medical Necessity and Coverage Criteria

Newly Diagnosed GBM Initial Therapy

Covered when all criteria are met for newly diagnosed histologically confirmed supratentorial glioblastoma.

Newly diagnosed GBM initial therapy

Treatment history: Debulking surgery has been completedcompleted
Treatment history: Radiation therapy has been completedcompleted
Concurrent medication: Individual is receiving temozolomide as the only cancer drugtemozolomide only
Functional status: Individual has KPS ≥60 or ECOG performance status ≤2KPS ≥60 or ECOG ≤2
Counseling: Individual has been counseled that the device must be worn at least 18 hours daily≥18 hours/day

Recurrent GBM Initial Therapy

Covered when all criteria are met for radiologically confirmed recurrent supratentorial glioblastoma.

Recurrent GBM initial therapy

Treatment exclusivity: The device is used as the only treatmentdevice only
Functional status: Individual has KPS ≥60 or ECOG performance status ≤2KPS ≥60 or ECOG ≤2
Counseling: Individual has been counseled that the device must be worn at least 18 hours daily≥18 hours/day

Continuation Therapy

Continuation beyond the initial 3 months is covered when all criteria are met for histologically confirmed supratentorial GBM.

Continuation therapy

Imaging: MRI has been performed no more than 2 months before the request and documents no evidence of disease progressionMRI ≤2 months prior; no progression
Qualifying treatment configuration
- Newly diagnosed GBM: Continues temozolomide as the only cancer drugtemozolomide only
- Recurrent GBM: Device is used as the only treatment

Electric tumor treatment field therapy for tumors other than glioblastoma is considered unproven and not medically necessary.

For recurrent glioblastoma, electric tumor treatment field therapy used concurrently with medical therapy, including bevacizumab or chemotherapy, is considered unproven and not medically necessary.

FDA approval alone is not a basis for coverage; coverage remains subject to the policy’s applicable medical-necessity criteria.

HCPCS code E0767 is not listed on the State of Idaho Medicaid Fee Schedule and therefore may not be covered by the State of Idaho Medicaid Program. Coverage may also be subject to Idaho Medicaid requirements for non-covered and excluded services.

Devices that generate electric tumor treatment fields are considered unproven and not medically necessary when the policy criteria are not met or for other indications outside the covered criteria.

Coding and Authorization Parameters

Applicable HCPCS CodesHCPCS

A4555	Electrode/transducer for use with electrical stimulation device used for cancer treatment, replacement only.
E0766	Electrical stimulation device used for cancer treatment, includes all accessories, any type.
E0767	Intrabuccal, systemic delivery of amplitude-modulated, radiofrequency electromagnetic field device, for cancer treatment, includes all accessories.

Applicable CodesHCPCS

E0767

HCPCS code E0767 is not on the State of Idaho Medicaid Fee Schedule and therefore may not be covered by the State of Idaho Medicaid Program.

Daily device wear

Required wear timeAt least 18 hours daily

Applies toInitial and continuation electric tumor treatment field therapy for newly diagnosed or recurrent supratentorial glioblastoma

DocumentationCounseling is required initially; actual device use must be documented for continuation

Performance status

Karnofsky thresholdKPS ≥ 60

ECOG thresholdECOG performance status ≤ 2

Applies to

Provider Submission and Denial Risks

Prior Authorization

Initial and Continuation Authorization

Submit clinical documentation supporting the applicable initial or continuation criteria when requesting authorization for electric tumor treatment field (TTF) therapy. When criteria are met, the initial authorization period is 3 months; continuation requests must document the requirements for approval beyond the initial period.

For newly diagnosed GBM, document that all initial-therapy criteria are met.
For recurrent GBM, document that all initial-therapy criteria are met.
For continuation, submit an MRI performed within 2 months of the request and documentation of treatment status, performance status, and device use of at least 18 hours daily.

Documentation Required

Medical Necessity Records

Maintain legible medical records that fully support the medical necessity of the requested TTF services and make them available upon request. Records may be required to assess clinical-criteria compliance but do not guarantee coverage.

Therapy Background

Electric tumor treatment field therapy uses low-intensity, intermediate-frequency alternating electric fields, generally approximately 100 to 300 kHz, delivered through transducer arrays to disrupt cell division in rapidly proliferating brain tumor cells.

Definitions and Abbreviations

Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status

PurposeMeasures how disease affects functioning, self-care, daily activity, and physical ability

ScaleScores range from 0 to 5

InterpretationLower scores indicate better function

Karnofsky Performance Status (KPS)

PurposeMeasures the ability of patients with cancer to perform ordinary tasks

ScaleScores range from 0 to 100

InterpretationHigher scores indicate better functional ability; a KPS of 60 means occasional assistance is required while most personal needs can be managed

Evidence by Line of Therapy

First-Line

Newly diagnosed GBM: Debulking surgery and radiation therapy completed; temozolomide is the only cancer drug; KPS ≥60 or ECOG ≤2; counseling regarding device use for at least 18 hours daily

FDA-approved device used according to labeled requirements; initial approval 3 months

Salvage

Recurrent GBM: After initial chemotherapy, device is used as the only treatment; KPS ≥60 or ECOG ≤2; counseling regarding device use for at least 18 hours daily

FDA-approved device used according to labeled requirements; initial approval 3 months

First-Line

Newly diagnosed glioblastoma maintenance therapy:

Biomarker and Molecular Characteristics

IDH mutation status

Evaluated statusIDH-wild-type recurrent glioblastoma

Study settingPatients with IDH-wild-type recurrent glioblastoma receiving TTFields at first recurrence were evaluated

FindingThe study examined clinical characteristics and genomic alterations that might predict responsiveness to TTFields

PTEN mutation status

Compared groupsPTEN-mutant versus PTEN-wild-type recurrent glioblastoma

PTEN-mutant findingTTFields-treated patients with PTEN-mutant disease had longer median post-progression survival than those with PTEN-wild-type disease

Therapy Regimens and Evidence Settings

Regimen	Indication	Coverage
Electric tumor treatment field therapy with temozolomide as the only cancer drug
Newly diagnosed supratentorial glioblastoma after debulking surgery and radiation therapy
Covered

Regimen	Indication	Coverage
Electric tumor treatment field therapy as the only treatment
Radiologically confirmed recurrent supratentorial glioblastoma after initial chemotherapy
Covered

Regimen	Indication	Coverage
Electric tumor treatment field therapy used concurrently with bevacizumab or chemotherapy
Recurrent glioblastoma
Not covered

Regimen	Indication	Coverage
TTFields plus maintenance temozolomide
Newly diagnosed glioblastoma after completion of concomitant radiochemotherapy
Covered

Regimen	Indication	Coverage
TTFields plus gemcitabine/nab-paclitaxel
Unresectable, locally advanced pancreatic adenocarcinoma
Experimental

Regimen	Indication	Coverage
Stereotactic radiosurgery followed by TTFields
Newly diagnosed NSCLC brain metastases suitable for stereotactic radiosurgery
Experimental

Regimen	Indication	Coverage
TTFields plus paclitaxel
Platinum-resistant epithelial ovarian cancer
Not covered

Regimen	Indication	Coverage
Optune Lua with docetaxel or an immune checkpoint inhibitor
Metastatic NSCLC developed during or after chemotherapy
Experimental

Regimen	Indication	Coverage
TTFields plus standard systemic therapy
Metastatic NSCLC progressing on or after platinum-based therapy
Experimental

Regimen	Indication	Coverage
TTFields plus paclitaxel
Platinum-resistant epithelial ovarian cancer
Experimental

Regimen	Indication	Coverage
Thoracic TTFields plus pemetrexed and cisplatin or carboplatin, followed by TTFields maintenance when appropriate
Front-line unresectable malignant pleural mesothelioma
Experimental

Regimen	Indication	Coverage
Radiotherapy plus concurrent and adjuvant temozolomide with alternating electric field therapy
Selected newly diagnosed supratentorial glioblastoma or other specified glioblastoma settings
Covered

Regimen	Indication	Coverage
Alternating electric field therapy as a recurrent-disease option, generally alongside consideration of clinical trials or systemic therapy
Selected recurrent or progressive glioblastoma
Experimental

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Idaho Only)

Policy CodePolicy CS146ID.C

Change TypeModified

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionSubmit the clinical request with documentation supporting the applicable initial or continuation criteria.

SourceLink

On This Page

Functional status: KPS ≥60 or ECOG performance status ≤2KPS ≥60 or ECOG ≤2

Adherence: Documentation shows use of the device for at least 18 hours daily≥18 hours/day

Initial and continuation therapy for newly diagnosed or recurrent supratentorial glioblastoma

Continuation MRI timing

Timing requirementMRI performed ≤ 2 months prior to the request

Imaging findingMRI must document no evidence of disease progression

Applies toContinuation beyond the initial 3 months of electric tumor treatment field therapy

Initial approval duration

Approval period3 months

Applies toInitial therapy for newly diagnosed or recurrent glioblastoma when all criteria are met

ContinuationSubsequent approval requires satisfaction of the continuation criteria

Include relevant medical history, physical examination, and pertinent diagnostic test or procedure results.
Maintain the supporting documentation in the patient's medical record.

Documentation Required

GBM Confirmation

Document the disease confirmation and location supporting the applicable indication. Newly diagnosed disease requires histologic confirmation of supratentorial GBM; recurrent disease requires radiologic confirmation of supratentorial GBM recurrence.

Newly diagnosed GBM: histologically confirmed supratentorial glioblastoma.
Recurrent GBM: radiologically confirmed recurrence in the supratentorial region of the brain.

Documentation Required

Clinical Criteria Documentation

Document each applicable clinical requirement before submitting the request. The record should show the qualifying treatment history, current cancer therapy, performance status, and counseling regarding required daily device wear.

Newly diagnosed GBM: debulking surgery completed; radiation therapy completed; temozolomide is the only cancer drug; KPS is at least 60 or ECOG is no greater than 2; and the individual has been counseled to wear the device at least 18 hours daily.
Recurrent GBM: initial chemotherapy has occurred; the device is the only treatment; KPS is at least 60 or ECOG is no greater than 2; and the individual has been counseled to wear the device at least 18 hours daily.
Continuation: MRI performed no more than 2 months before the request shows no disease progression; qualifying therapy remains the only cancer treatment as applicable; performance status remains within criteria; and device use is documented at least 18 hours daily.

Denial Risk

Nonqualifying Indication or Concurrent Therapy

Flag requests that fall outside the stated medically necessary indications. TTF devices are unproven and not medically necessary when the applicable criteria are not met, including use for tumors other than GBM or concurrent medical therapy for recurrent GBM.

Treatment of tumors other than GBM is not an eligible indication.
TTF therapy used with concurrent medical therapy, such as bevacizumab or chemotherapy, for recurrent GBM is unproven and not medically necessary.

Denial Risk

Initial Newly Diagnosed GBM Criteria Not Met

Expect denial risk for an initial newly diagnosed GBM request when any required criterion is absent or cannot be documented. The request must involve histologically confirmed supratentorial GBM and completion of the required treatment and clinical steps.

Debulking surgery has not been completed.
Radiation therapy has not been completed.
Temozolomide is not the only cancer drug.
KPS is below 60 or ECOG performance status is above 2.
The individual has not been counseled to wear the device at least 18 hours daily.
Histologic confirmation of newly diagnosed supratentorial GBM is not documented.

Denial Risk

Initial Recurrent GBM Criteria Not Met

Expect denial risk for an initial recurrent GBM request when the recurrence, treatment setting, or required clinical criteria are not documented. Recurrent disease must be radiologically confirmed in the supratentorial region and the TTF device must be used as the only treatment after initial chemotherapy.

Radiologic confirmation of supratentorial recurrent GBM is not documented.
The device is not being used as the only treatment.
Initial chemotherapy has not occurred or is not documented.
KPS is below 60 or ECOG performance status is above 2.
The individual has not been counseled to wear the device at least 18 hours daily.

Denial Risk

Continuation Criteria Not Met

Continuation beyond the initial 3 months requires current evidence that the disease has not progressed and that all applicable treatment, performance-status, and adherence requirements remain satisfied.

No MRI was performed within 2 months before the request, or the MRI documents disease progression.
Newly diagnosed GBM is no longer being treated with temozolomide as the only cancer drug, or recurrent GBM is not being treated with the device as the only treatment.
KPS is below 60 or ECOG performance status is above 2.
Device use of at least 18 hours daily is not documented.

Denial Risk

FDA Approval Does Not Independently Establish Coverage

FDA approval is informational and does not independently establish coverage. Coverage still depends on the UnitedHealthcare policy criteria, including the applicable disease confirmation, treatment requirements, performance status, counseling, and authorization requirements.

FDA approval alone is not a basis for coverage.

Billing Rule

Idaho Medicaid Fee-Schedule Exclusion Risk

HCPCS E0767 is not listed on the State of Idaho Medicaid Fee Schedule and therefore may not be covered by the State of Idaho Medicaid Program.

Check the Idaho Medicaid Provider Handbook for non-covered and excluded services requirements before billing or submitting a request.
Fee-schedule exclusion may create a separate coverage or payment risk even when clinical criteria are met.

Supratentorial

LocationUpper portion of the brain

Included structuresCerebrum, ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve

Policy relevanceThe policy addresses newly diagnosed and recurrent supratentorial glioblastoma

Temozolomide

Drug classOral alkylating chemotherapy drug

UseUsed in the treatment of some brain cancers

Glioblastoma roleIdentified in the policy as a first-line treatment for glioblastoma

TTFields

Treatment typeElectric tumor treatment field therapy

Field characteristicsLow-intensity, intermediate-frequency alternating electric fields

DeliveryDelivered through transducer arrays to affect rapidly dividing cancer cells

ndGBM

MeaningNewly diagnosed glioblastoma

Disease statusBefore recurrence or progression

Common policy settingInitial therapy after debulking surgery and radiation therapy, with temozolomide as the only cancer drug

rGBM

MeaningRecurrent glioblastoma

Disease statusGlioblastoma that has recurred after prior treatment

Policy settingElectric tumor treatment field therapy may be considered after initial chemotherapy as the only treatment

TTFields compliance

DefinitionPercentage of time each month that TTFields are delivered

Outcome associationIn an EF-14 subgroup analysis, 50% compliance was associated with improved progression-free and overall survival compared with temozolomide alone

Higher useOutcomes improved as compliance increased; compliance above 90% was associated with extended median and 5-year survival rates

Overall survival (OS)

DefinitionTime from randomization to death

Endpoint useUsed as a primary or secondary survival endpoint in clinical trials

ExampleThe INNOVATE-3 trial defined overall survival from randomization to death

Glioblastoma has been resected or biopsied and concomitant radiochemotherapy has been completed; TTFields is added to maintenance temozolomide.

Evidence from the EF-14 trial.

Salvage

Recurrent glioblastoma: TTFields was studied at first recurrence or in recurrent glioblastoma, including comparisons with best standard care and exploratory combination with bevacizumab.

Evidence was observational or comparative and included limitations; no operational coverage criterion is stated in this window.

Second-Line

Metastatic NSCLC after platinum progression: Metastatic NSCLC has progressed on or after platinum-based therapy; TTFields is used with standard systemic therapy.Prior platinum-based therapy required

Based on the LUNAR phase 3 trial population.

First-Line

Front-line unresectable malignant pleural mesothelioma: Unresectable malignant pleural mesothelioma is treated with thoracic TTFields plus pemetrexed and cisplatin or carboplatin; maintenance TTFields continued for participants without progression after chemotherapy.Up to six 21-day chemotherapy cycles followed by maintenance until progression, decision, or unacceptable toxicity

Based on the single-arm STELLAR phase 2 trial.

First-Line

Newly diagnosed glioblastoma: Selected patients with newly diagnosed glioblastoma may receive alternating electric field therapy with adjuvant temozolomide after radiotherapy and concurrent temozolomide, depending on age, performance status, and MGMT promoter methylation status.NCCN-described patients generally have good performance status, KPS at least 60; ASCO/SNO recommendation specifies newly diagnosed supratentorial IDH-wild-type CNS WHO grade 4 disease after chemoradiation

NCCN lists this as a preferred or category 1 option in specified settings; ASCO/SNO characterizes the recommendation as weak with moderate-quality evidence.

Salvage

Recurrent or progressive glioblastoma: For recurrent or progressive glioblastoma, guidelines discuss alternating electric field therapy as an option in selected patients, but the EF-11 trial did not demonstrate a clear survival advantage and guideline recommendations are divided or advise against use.NCCN category 2B in selected glioblastoma settings; NICE recommends not offering TTFields for recurrent high-grade glioma

Clinical-trial participation is generally preferred when eligible.

The findings were retrospective and based on a small sample size

MGMT promoter methylation

Compared groupsMGMT promoter methylated versus unmethylated

Treatment associationTTFields combination therapy was associated with increased survival regardless of MGMT promoter methylation status

Clinical contextThe analysis evaluated treatment strategies based on MGMT promoter methylation status in newly diagnosed glioblastoma

Actionable mutations

Required findingNo known actionable mutations

Study settingNewly diagnosed non-small-cell lung cancer brain metastases suitable for stereotactic radiosurgery

Trial treatmentParticipants were randomized to stereotactic radiosurgery followed by TTFields or stereotactic radiosurgery alone

MGMT promoter methylation

Possible resultsMethylated, unmethylated, or indeterminate

Treatment relevanceMGMT promoter methylation helps inform selection of glioblastoma treatment approaches

Temozolomide contextTemozolomide may be more active in methylated tumors, while activity in unmethylated tumors is probably marginal

IDH status

Possible statusIDH-wild type or IDH1/2-mutant

Classification roleIDH status is used in classification and treatment recommendations for glioblastoma and diffuse astrocytic or oligodendroglial tumors

Guideline contextASCO/SNO describes alternating electric field therapy for newly diagnosed supratentorial IDH-wild-type CNS WHO grade 4 disease after chemoradiation

1p/19q codeletion and H3 mutation

Molecular findings1p/19q codeleted or H3-mutated

Disease contextThese findings appear in recurrent or progressive high-grade glioma disease categorization

Guideline contextNCCN recommendations discuss these molecular categories when considering clinical trials, systemic therapy, reirradiation, or other options