ModifiedUnitedHealthcarePolicy CS146OH.E

Electric Tumor Treatment Field Therapy (for Ohio Only)

This policy governs coverage and medical necessity criteria for electric tumor treatment field (TTF) therapy for members in the state of Ohio and specifies clinical indications, documentation, and applicable codes.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Ohio Only)

Policy CodePolicy CS146OH.E

Change TypeMaterial coverage language added for rGBMdefinitions and documentation language added

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and document that device will be used as the only treatment, member has KPS ≥ 60 or ECOG ≤ 2, and counseling on wearing device ≥18 hours/day.

SourceLink

POLICY UPDATE CHANGES

Removed language indicating computer software used for therapeutic radiology clinical treatment planning in conjunction with electric TTF therapy is unproven and not medically necessary.

Added documentation language stating coverage determinations follow federal, state (OAC), or contractual requirements and that medical records supporting medical necessity may be required.

Added definitions for ECOG Performance Status, Karnofsky Performance Status (KPS), and supratentorial.

≥18 h/dayDevice wear time

3 monthsInitial approval duration

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

KPS ≥60 / ECOG ≤2Performance status threshold

≥22 yrsMinimum non‑experimental age

50%Compliance threshold

695Key trial size (EF-14)

Coverage and Medical Necessity Criteria

Initial treatment for recurrent supratentorial glioblastoma

Covered when ALL of the following are met for initial treatment of radiologically confirmed recurrent supratentorial glioblastoma (rGBM):

rGBM coverage criteria: Use of an FDA‑approved tumor treating fields (TTF) device according to FDA labeled indications, contraindications, warnings, and precautions

rGBM coverage criteria: Device is used as the only treatment during the initial approval period

Policy requires single‑modality use for the indicated initial coverage period.

rGBM coverage criteria: Individual has a Karnofsky Performance Status (KPS) ≥ 60 OR Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

rGBM coverage criteria: Individual has been counselled that the electric TTF device must be worn at least 18 hours daily≥ 18 hours/day

Providers should document counseling on expected adherence and array‑related skin adverse events.

rGBM coverage criteria: Initial approval duration: 3 months when all above criteria are met3 months

Newly diagnosed supratentorial glioblastoma — adjunct to maintenance temozolomide

Covered when ALL of the following are met

Population and timing: Patient is an adult with newly diagnosed supratentorial glioblastoma who has completed standard concurrent radiotherapy and temozolomide and is entering maintenance temozolomide treatment

Reflects EF‑14 enrollment criteria and FDA supplemental approval

Device use expectation: Plan for TTFields (Optune) to be applied during maintenance temozolomide with documentation of counseling on expected array‑related skin adverse events and adherence expectations>=50% monthly compliance expected to confer benefit; higher compliance associated with greater benefit

Based on EF‑14 trial and compliance analyses (Toms et al.).

Regulatory context: Use consistent with FDA supplemental PMA for Optune with temozolomide for newly diagnosed supratentorial GBM following completion of radiation therapy

FDA supplemental approval is informational and enrollment/timing should match trial context.

Recurrent glioblastoma

Covered when ALL of the following are met

FDA indication: Patient is an adult with recurrent or progressive glioblastoma after prior surgery, radiation, and chemotherapy

Reflects the Optune initial FDA approval for recurrent GBM and supporting evidence.

Consideration of alternatives: Consider patient preferences and tradeoffs: TTFields may avoid chemotherapy‑associated systemic adverse events but increases skin reactions and falls; document rationale for choosing TTFields over or in addition to systemic therapy

Based on ECRI assessment comparing Optune to best standard care.

Initial therapy (rGBM)

Covered when ALL of the following are met for initial treatment of radiologically confirmed recurrent supratentorial glioblastoma (rGBM):

Initial rGBM coverage criteria: Device is an FDA‑approved electric TTF device used according to FDA labeled indications, contraindications, warnings, and precautions

Initial rGBM coverage criteria: Device is used as the only treatment

Failure to document single‑modality use may result in noncoverage or denial.

Initial rGBM coverage criteria: Individual has a Karnofsky Performance Status (KPS) ≥ 60 OR Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

Initial rGBM coverage criteria: Individual has been counselled that the electric TTF device must be worn at least 18 hours daily

Electric tumor treatment field (TTF) therapy for individuals 22 years of age is considered experimental or investigational and not approved due to lack of FDA‑approved indications for this age group.

The National Institute for Health and Care Excellence (NICE) guidance states for newly diagnosed grade IV glioma (glioblastoma): do not offer TTFields as part of routine management. NICE also recommends against offering TTFields for recurrent high‑grade glioma and encourages consideration of performance status, patient preferences, time from last treatment, and other standard options when deciding management.

This policy and its coverage criteria apply specifically to supratentorial glioblastoma. FDA approvals for the Optune system are provided for informational purposes only and do not, by themselves, constitute a basis for coverage decisions under this policy.

A Hayes health technology assessment rated available evidence for some TTFields applications as a rating C, characterizing the body of evidence as small and of low quality; such assessments note limited, low‑quality data supporting outcomes and should be considered when interpreting clinical evidence.

Previously included language regarding certain radiotherapy planning software has been removed from the policy; no additional residual or removed content is specified in this section.

Applicable Codes and Coding Notes

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

FDA PMA referencesmixed

P100034	FDA Premarket Approval identifier referenced for Optune initial PMA
P100034S013	FDA supplemental PMA referenced for Optune with temozolomide

Device compliance — reported association with improved survival (≥ 75% daily usage mentioned)

Reported associationCompliance ≥ 75% daily usage associated with significantly lower mortality risk and improved overall survival in meta-analysis

Source studyLi et al. systematic review and meta-analysis (2022) reporting benefit with compliance ≥ 75%

Limitations notedAnalysis limited by heterogeneity and small number of included studies

TTFields monthly compliance — >= 50% associated with improved PFS/OS; higher compliance correlates with better outcomes

Monthly compliance threshold>= 50% monthly compliance associated with improved progression-free and overall survival versus temozolomide alone

Dose-response

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tumor Treating Fields (TTFields; Optune) devices. Requests will be reviewed for medical necessity using InterQual® CP: Durable Medical Equipment, Tumor Treatment Field Therapy (TTFT) Devices. Submit prior authorization for initial therapy and any continuation or renewal requests before services are rendered.

Prior authorization required for Optune/TTFields
InterQual CP used as primary medical necessity criteria

Prior Authorization

Prior Authorization for Initial Therapy

For initial therapy, an authorization may be approved for an initial 3-month period when all clinical criteria are met (see coverage criteria). Ensure the request documents completion of initial chemotherapy and, when applicable, prior completion of radiochemotherapy for newly diagnosed patients before adding TTFields to maintenance temozolomide.

Authorize initial 3 months of TTFields when ALL criteria met
Document prior completion of radiochemotherapy when claiming adjunct use to maintenance TMZ

Clinical Background and Evidence Summary

Tumor Treating Fields (TTFields) deliver alternating low‑intensity, intermediate‑frequency electric fields (typically in the range used by approved devices) that interfere with mitotic processes in dividing tumor cells. The Optune system is a portable device with scalp transducer arrays that are worn on the head and are intended to be used for multiple hours per day; clinical protocols and this policy counsel wearing the device for at least 18 hours/day to achieve the expected therapeutic exposure. TTFields have been studied both as monotherapy for recurrent glioblastoma and as an adjunct to maintenance temozolomide in newly diagnosed supratentorial glioblastoma.

Definitions and Performance Status Scales

ECOG Performance Status — definition and threshold (ECOG <= 2)

DefinitionECOG Performance Status: scale 0–5 measuring functional status; lower score = better function

Coverage thresholdCoverage requires ECOG Performance Status ≤ 2 (ambulatory and capable of selfcare but unable to work)

Use in policyECOG added to policy definitions and required as an alternative performance threshold for rGBM coverage

Karnofsky Performance Status (KPS) — definition and threshold (KPS >= 60)

DefinitionKarnofsky Performance Status (KPS): 0–100 scale assessing ability to perform ordinary tasks; higher score = better function

Coverage thresholdCoverage requires KPS ≥ 60 (requires occasional assistance but able to care for most personal needs)

Policy Updates and Material Changes

01/01/2026material_changeLatest

Added proven and medically necessary language for initial treatment of radiologically confirmed recurrent supratentorial glioblastoma (rGBM) with FDA‑approved electric TTF devices when used per FDA labeling and when specified clinical criteria are met (device used as sole treatment; KPS ≥ 60 or ECOG ≤ 2; counseling to wear device ≥18 hours/day); initial 3 months of therapy approved when criteria met.

01/01/2026removed_language

Removed prior statement that computer software used for therapeutic radiology clinical treatment planning in conjunction with electric TTF therapy is unproven and not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Ohio Only)

Policy CodePolicy CS146OH.E

Change TypeMaterial coverage language added for rGBMdefinitions and documentation language added

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and document that device will be used as the only treatment, member has KPS ≥ 60 or ECOG ≤ 2, and counseling on wearing device ≥18 hours/day.

SourceLink

On This Page

Document counseling and adherence expectations in the medical record.

Initial rGBM coverage criteria: Initial therapy approval duration: 3 months when all above criteria are met3 months

Providers should obtain prior authorization; medical records must support medical necessity.

Improved outcomes observed as compliance increased; >90% associated with median survival ~24.9 months and higher 5-year survival

Analysis methodToms et al. (2019) subgroup analysis of EF-14 using device-recorded monthly usage and Cox modeling controlling for key covariates

Device wear time — counseling requirement (>= 18 hours/day)

Counseling requirementMembers must be counselled that the electric TTF device must be worn at least 18 hours daily

ContextCounseling is part of coverage criteria for initial treatment of radiologically confirmed recurrent supratentorial glioblastoma

Documentation riskFailure to document counseling about wear time may result in noncoverage or denial

Initial approval duration — initial approved period when criteria met (3 months)

Initial approval periodInitial approved duration when criteria met: 3 months

ConditionApplies when all coverage criteria for initial rGBM treatment are satisfied

Authorization noteProviders should obtain prior authorization consistent with plan and state requirements for the initial 3‑month approval

Denial Risk

Medical Necessity Evaluation and Denial Risk

Requests that do not meet the clinical criteria or lack required documentation may be denied. Medical necessity determinations will follow Ohio Administrative Code and the member's contractual benefit terms. Providers should be aware that services described as unproven or lacking required evidence will be evaluated and may be denied.

Failure to meet InterQual or policy criteria increases denial risk
Services listed as unproven will be evaluated per OAC and contract terms

Note

Timing Relative to Radiochemotherapy

Do not submit requests for patients who progressed during radiochemotherapy as these patients were excluded from randomized trials; document timing relative to radiochemotherapy (e.g., median time from diagnosis to randomization ~3.8 months in Stupp et al.). For newly diagnosed use, indicate that enrollment/randomization occurred after completion of radiochemotherapy and that the patient did not have progression during that course.

Document that patient did not progress during radiochemotherapy
Include dates for diagnosis, radiotherapy completion, and planned start of TTFields

Denial Risk

Coverage Criteria Documentation Risks

Coverage depends on meeting and documenting specific coverage criteria. Failure to document single‑modality use during initial rGBM coverage period, required performance status thresholds (KPS ≥ 60 or ECOG ≤ 2), counseling on device wear time (≥18 hours/day), or prior therapy completion (chemotherapy and/or radiochemotherapy as applicable) may lead to denial.

Document single‑modality use when indicated
Document KPS or ECOG performance status
Document counseling that device must be worn ≥ 18 hours/day
Document completion of prior chemotherapy and/or radiochemotherapy

Documentation Required

Medical Records Required

Maintain comprehensive medical records to support the medical necessity of TTFields. Records should include relevant medical history, physical examination, pathology/imaging confirming supratentorial GBM or rGBM, operative notes (if applicable), dates and details of prior chemotherapy and radiotherapy, performance status assessments, and counseling notes regarding device use. Documentation must be legible, retained in the patient's record, and provided upon request.

History, physical exam, and pertinent diagnostic test results
Operative and radiotherapy reports, chemotherapy dates and regimens
Performance status (KPS/ECOG) and counseling documentation
Records must be available upon request and meet federal/state/contractual requirements

Documentation Required

Medical Records and Coverage Governance

Benefit coverage is governed by federal, state (Ohio Administrative Code), or contractual requirements. Medical records and other documentation used for reviews must meet those requirements and be available upon request. Inclusion of FDA approval is informational and does not by itself guarantee coverage.

Records must comply with federal/state/contractual requirements
InterQual is primary criteria; if not applicable, UnitedHealthcare policies/guidelines may be used

Note

Sequence With Standard Therapies

TTFields (Optune) is intended as an adjunct to standard therapy when indicated and should not replace standard-of-care radiotherapy or temozolomide. For newly diagnosed GBM, Optune is used in combination with maintenance temozolomide after completion of radiochemotherapy per EF-14 trial; for recurrence, TTFields may be used after initial chemotherapy when criteria are met.

TTFields is used in combination with maintenance TMZ for ndGBM after radiochemotherapy
Do not substitute TTFields for radiotherapy or concomitant chemoradiation

Prior Authorization

Single‑Modality Requirement

During the indicated initial coverage period for rGBM, the device must be used as the only anti‑tumor treatment (single‑modality) per policy criteria. Ensure documentation explicitly states that no concurrent anti‑tumor therapies were delivered during the initial approved 3‑month period.

Document that TTFields was the only active anti‑tumor therapy during the initial coverage period
Initial approval typically limited to 3 months when criteria met

Use in policyKPS definition and threshold were added to policy as criteria for rGBM coverage

Supratentorial — anatomic definition referenced in coverage criteria

DefinitionSupratentorial: upper portion of the brain including the cerebrum, ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve

Coverage scopePolicy coverage applies specifically to supratentorial glioblastoma recurrence

Location requirementCriteria and approvals reference supratentorial location for rGBM therapy eligibility

Optune / TTFields — device definition and FDA approval context

Device identityOptune / TTFields: medical device delivering alternating low‑intensity electric fields (tumor treating fields)

FDA approval contextOptune received initial FDA PMA for recurrent GBM (adults ≥22) and supplemental PMA for use with temozolomide in newly diagnosed supratentorial GBM after radiation

Coverage noteFDA approval is informational; coverage is determined by policy clinical criteria rather than FDA approval alone

Compliance threshold — monthly usage percentage (50% threshold referenced)

Defined thresholdCompliance threshold referenced: monthly usage ≥ 50% associated with improved PFS and OS

Higher compliance benefitOutcomes improved progressively with higher compliance; >90% associated with markedly longer median survival

MeasurementCompliance measured as percent monthly TTFields delivery from device-recorded usage data (EF-14 analyses)

KPS repeated definition added in policy changes (threshold for coverage KPS >= 60)

KPS definition addedPolicy additions included definition of Karnofsky Performance Status (KPS) with coverage threshold set at KPS ≥ 60

Policy change dateDefinition and threshold added in 01/01/2026 policy revision

Use in criteriaKPS ≥ 60 is required (or ECOG ≤ 2) for initial rGBM coverage

ECOG repeated definition added in policy changes (threshold for coverage ECOG <= 2)

ECOG definition addedPolicy additions included the Eastern Cooperative Oncology Group (ECOG) Scale definition

Coverage thresholdECOG Performance Status ≤ 2 specified as a coverage threshold (alternative to KPS ≥ 60)

Policy change dateDefinition and threshold incorporated in the 01/01/2026 revision

Supratentorial definition added in policy changes (anatomic region specification)

Supratentorial definition addedPolicy additions included a definition of supratentorial as the upper portion of the brain (cerebrum and associated structures)

Coverage implicationAnatomic specification clarifies that coverage applies only to supratentorial GBM recurrence

Revision contextDefinition added in the 01/01/2026 policy update

01/01/2026administrative_change

Added medical records documentation requirements specifying that benefit coverage is determined by federal, state, or contractual requirements; medical records supporting medical necessity may be required and must be legible and available upon request.

01/01/2026definitions_added

Added definitions for ECOG Performance Status, Karnofsky Performance Status (KPS), and supratentorial.