ModifiedUnitedHealthcarePolicy CS146KS.02

Electric Tumor Treatment Field Therapy (for Kansas Only)

Policy governs coverage and medical necessity criteria for electric tumor treatment field therapy (TTF/TTFields) for members in Kansas, including indications, documentation, and applicable billing codes.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Kansas Only)

Policy CodePolicy CS146KS.02

Change TypeMaterial coverage and documentation updates

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization documenting InterQual criteria and supporting trial/guideline evidence and ensure medical record documents KPS/ECOG and counseling on ≥18 hours/day device wear.

SourceLink

POLICY UPDATE CHANGES

Added language that use of FDA‑approved devices to generate electric TTF is proven and medically necessary for initial treatment of radiologically confirmed supratentorial recurrent glioblastoma when used per FDA labeling and when specific clinical criteria are met.

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

Added requirements and clarifications about medical records documentation needed to support medical necessity determinations.

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

Removed CPT code 77299 from the Applicable Codes section.

≥18h/dayminimum daily device wear time

3 monthsinitial approved duration for rGBM

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KPS ≥60 / ECOG ≤2

performance status requirement

695EF-14 trial participants

20.9 momedian OS (TTFields+TMZ)

Coverage and Medical Necessity Criteria

Initial therapy for recurrent GBM (supratentorial)

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

rGBM coverage criteria: 1) Use of an FDA‑approved device to generate electric tumor treatment fields (TTF) after initial chemotherapy when used according to FDA labeled indications, contraindications, warnings, and precautions; 2) The device is used as the only treatment; 3) Individual has a Karnofsky Performance Status (KPS) score of ≥ 60 OR ECOG Performance Status ≤ 2; 4) Individual has been counselled that the electric TTF device must be worn at least 18 hours daily.Initial approval = 3 months

Refer to InterQual Durable Medical Equipment, Tumor Treatment Field Therapy (TTFT) Devices for full clinical coverage criteria.

Covered when supported by trial evidence and guideline recommendation

Evidence and guideline context supporting use of TTFields in newly diagnosed supratentorial GBM after chemoradiation:

EF-14 trial primary population: Adult patients with newly diagnosed, supratentorial glioblastoma who have completed concomitant radiochemotherapy (population randomized in EF-14).

EF-14 randomized participants (n=695) showed improved PFS and OS when TTFields was added to maintenance temozolomide.

Guideline support: NCCN (2022; updated 2025) lists alternating electric field therapy as an option for individuals with good performance status (KPS ≥ 60) and supratentorial disease; ASCO-SNO (2022) states alternating electric field therapy may be added to adjuvant TMZ after chemoradiation (weak recommendation).

Guideline recommendations support use in selected patients.

Safety considerations: Most common device-related adverse events are reversible scalp skin reactions; systemic adverse event rates were similar between TTFields+TMZ and TMZ alone in trial data; post-marketing surveillance (>11,000 patients) reported mainly mild to moderate skin reactions under transducer arrays.

EF-14 reported skin toxicity in 52% receiving TTFields+TMZ versus none in TMZ alone; systemic AE frequency comparable.

Initial therapy for recurrent supratentorial GBM

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

Initial rGBM coverage criteria: 1) Use of an FDA‑approved device to generate electric tumor treatment fields (TTF) after initial chemotherapy when used according to FDA labeled indications, contraindications, warnings, and precautions; 2) The device is used as the only treatment; 3) Individual has a Karnofsky Performance Status (KPS) score of ≥ 60 OR ECOG Performance Status ≤ 2; 4) Individual has been counselled that the electric TTF device must be worn at least 18 hours daily; 5) When all of the above criteria are met, an initial 3 months of electric TTF therapy will be approved.Initial approval = 3 months

Apply only to supratentorial rGBM.

TTF therapy is considered experimental or investigational for individuals younger than 22 years because there are no FDA‑approved indications for this age group.

The National Institute for Health and Care Excellence (NICE) guidance (2018; updated 2021) explicitly recommends: do not offer tumor treating fields (TTF) as part of management of newly diagnosed grade IV glioma (glioblastoma).

Coverage under this policy is limited to glioblastoma located in the supratentorial region; TTF use for non‑supratentorial GBM is not covered by these criteria.

Coverage rationale references the InterQual Durable Medical Equipment, Tumor Treatment Field Therapy (TTFT) criteria for detailed clinical coverage rules and notes that TTF is considered proven and medically necessary in specified circumstances when those criteria and the policy requirements are met.

NICE additionally states for recurrent high‑grade glioma that multidisciplinary decision‑making should consider KPS, patient preferences, time from last treatment and tumor molecular markers, and that the guideline advises: do not offer tumor treating fields (TTF) as part of management of recurrent high‑grade glioma.

Use of an FDA‑approved device alone does not by itself establish coverage. When device or software is used outside FDA‑labeled indications, or when clinical use is not supported by documentation in the medical record, the service may be considered not medically necessary; the patient medical record must fully support medical necessity and be made available upon request.

Applicable Codes and Operational Coding Details

Applicable HCPCS / procedure 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

Device/Product Codesmixed

NZK	FDA product code referenced for Optune supplemental approvals

Device/Product Codes referencedmixed

NZK	FDA product code referenced for Optune supplemental approvals

Minimum daily wear time / compliance

Minimum daily wear time≥ 18 hours per day; literature notes ≥75% (and higher) compliance associated with improved survival

Counseling requirementMember must be counselled that the device must be worn at least 18 hours daily

Evidence on complianceMeta-analysis reported significantly lower OS risk when TTFields compliance ≥75%

Initial approval duration

Initial approval durationInitial approval: 3 months for radiologically confirmed recurrent supratentorial GBM when coverage criteria are met

Condition for approval

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required: Coverage is contingent on meeting the InterQual® Durable Medical Equipment, Tumor Treatment Field Therapy (TTFT) criteria. Requests must reference and demonstrate that the individual meets the InterQual DME Tumor Treatment Field Therapy criteria and that the device will be used consistent with FDA-labeled indications, contraindications, warnings, and precautions.

Prior authorization required prior to initiation of therapy
InterQual criteria must be cited in the prior authorization submission

Prior Authorization

Document Clinical Trial and Guideline Evidence

Prior authorization submissions must document clinical trial and guideline evidence supporting the requested use. Include key EF-14 trial results (improvements in progression-free survival and overall survival with TTFields plus temozolomide versus temozolomide alone) and cite applicable guideline recommendations (e.g., NCCN, EANO) when submitting for initial or recurrent GBM.

Include pivotal EF-14 trial data: median PFS 6.7 vs 4.0 months; median OS 20.9 vs 16.0 months (TTFields+TMZ vs TMZ alone)

Background and Evidence Summary

Tumor Treating Fields (TTF) are a noninvasive therapy that deliver low‑intensity, intermediate‑frequency electric fields to disrupt mitosis in proliferating tumor cells. The Optune system (formerly NovoTTF‑100A) operates in the 100–300 kHz frequency range and is delivered via transducer arrays placed on the scalp; therapy is intended to be worn many hours per day to achieve clinical effect.

Definitions and Abbreviations

Karnofsky Performance Status (KPS)

KPS scale range0–100

KPS = 60 exampleRequires occasional assistance but is able to care for most personal needs

Use in policyKPS used to determine eligibility for TTFields coverage (threshold ≥ 60)

ECOG Performance Status

ECOG scale range0–5

ECOG 0Fully active, able to carry on all pre-disease performance without restriction

ECOG 1–2 summary1 = restricted in strenuous activity but ambulatory; 2 = ambulatory and capable of selfcare but unable to work, up >50% of waking hours

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Kansas Only)

Policy CodePolicy CS146KS.02

Change TypeMaterial coverage and documentation updates

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization documenting InterQual criteria and supporting trial/guideline evidence and ensure medical record documents KPS/ECOG and counseling on ≥18 hours/day device wear.

SourceLink

On This Page

Approval applies when device is used as the only treatment and performance status and counseling criteria are satisfied

Benefit limitsCoverage subject to applicable federal, state, or contractual requirements and documentation may be requested

Performance status requirement

Performance status requirementKarnofsky Performance Status (KPS) ≥ 60 OR ECOG Performance Status ≤ 2

KPS exampleKPS 60 = requires occasional assistance but is able to care for most personal needs

ECOG examplesECOG 0 = fully active; ECOG 2 = ambulatory and capable of selfcare but unable to work, up >50% of waking hours

TTFields monthly compliance threshold

Monthly compliance threshold50% monthly TTFields compliance associated with improved PFS and OS versus TMZ alone

Dose–response relationshipImproved outcomes as compliance increases; >90% compliance linked to longest median survival (median 24.9 months in subgroup)

MeasurementCompliance assessed from device usage data as percent monthly delivery

Minimum daily wear time

Minimum daily wear time (policy counseling)Members must be counselled to wear the device ≥ 18 hours/day

Policy contextCounseling is a required element of coverage for initial rGBM therapy when other clinical criteria are met

Clinical rationaleHigher daily wear time/compliance correlates with better PFS/OS outcomes per trial and meta-analysis evidence

Performance status threshold

Performance status threshold (restatement)KPS ≥ 60 OR ECOG ≤ 2 required for coverage of initial rGBM therapy

KPS interpretationKPS scores range 0–100; KPS 60 indicates requires occasional assistance but can care for most personal needs

ECOG interpretationECOG scale 0–5; ECOG 0 fully active, ECOG 2 ambulatory and selfcare-capable but unable to work

Reference guideline context: NCCN and EANO statements regarding TTFields

Document device-specific FDA approval history (PMA and supplemental PMAs)

Prior Authorization

Initial Authorization Period

Initial authorization: When all clinical criteria are met and documentation is provided, initial approval will be granted for 3 months of electric tumor treatment field (TTF) therapy for radiologically confirmed supratentorial recurrent GBM (rGBM).

Initial authorization period = 3 months when criteria satisfied
Device must be used as the only treatment for rGBM when covered per policy

Documentation Required

Documentation and Medical Records Requirements

Medical record documentation must fully support medical necessity. Lack of sufficient documentation to demonstrate that the member meets the policy’s clinical criteria may result in denial of the prior authorization or claim.

Medical record must include relevant history, physical exam, and pertinent diagnostic test results
Documentation must be legible, maintained in the medical record, and made available upon request
Insufficient or missing documentation may trigger denial

Documentation Required

FDA Approval Information (Informational Only)

FDA approval alone does not guarantee coverage. Prior authorization and evidence that the patient meets the policy’s clinical criteria (including InterQual criteria and documented trial/guideline support) are required; FDA PMA or supplemental approvals should be included in submissions but are not sufficient by themselves for approval.

Include FDA PMA and supplemental approval references in the submission (e.g., Optune PMA P100034 and supplements)
Coverage decisions rely on meeting policy and InterQual clinical criteria, not solely on FDA approval

Note

Guideline Context and Standard of Care

Guideline context: In submissions, document the standard of care sequencing and where TTFields fit as an adjunct. Cite that standard treatment for newly diagnosed IDH‑wildtype glioblastoma includes maximal safe resection when feasible followed by involved-field radiotherapy with concurrent temozolomide and adjuvant temozolomide; TTFields are an adjunctive option per NCCN for appropriate patients and have specific use recommendations for supratentorial disease.

Describe prior treatments (surgery ± radiotherapy + concurrent/adjuvant temozolomide) and how TTFields are being sequenced
Note NCCN footnote: Alternating electric field therapy is an option only for supratentorial disease

Step Therapy

Step Therapy / Sequencing

Step therapy/sequencing: No formal step therapy is specified in this policy. When covered for rGBM, the device is indicated to be used as the only tumor-directed therapy per policy criteria. Document prior therapies and rationale if therapy sequencing differs from typical care pathways.

No step therapy required by policy
For rGBM coverage the device must be used as the only treatment per policy language

Supratentorial

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

Policy relevanceCoverage for rGBM limited to supratentorial tumor location

SourceNational Cancer Institute (NCI) definition cited in policy

Optune / TTFields

Device identityOptune (formerly NovoTTF-100A) — FDA-approved tumor treating fields device

FunctionDelivers low-intensity alternating electric fields (TTFields) via transducer arrays placed on the scalp for supratentorial GBM

Regulatory historyInitial FDA PMA (2011) and supplemental approval for use with temozolomide in newly diagnosed supratentorial GBM

EF-14 trial

Trial identifierEF-14 — Phase III randomized clinical trial comparing TTFields plus maintenance temozolomide versus temozolomide alone

Primary populationAdults with newly diagnosed, supratentorial glioblastoma after completion of radiochemotherapy (n=695)

Key outcomesImproved PFS and OS with TTFields+TMZ vs TMZ alone (MOS 20.9 vs 16.0 months)

ECOG Performance Status

ECOG referenceEastern Cooperative Oncology Group (ECOG) Scale of Performance Status as defined in policy (0–5)

UsageECOG used to determine coverage eligibility (threshold ≤ 2)

ExamplesECOG 0 fully active; ECOG 2 ambulatory and capable of selfcare but unable to work

Karnofsky Performance Status (KPS)

KPS referenceKarnofsky Performance Status (KPS) scale (0–100) as defined in policy

InterpretationKPS 60 = requires occasional assistance but able to care for most personal needs; used as coverage threshold (≥60)

Use caseKPS and ECOG both accepted to assess functional status for TTFields eligibility

Supratentorial

Supratentorial definition (policy)Anatomic region of the brain above the tentorium, including cerebrum and associated structures

Coverage implicationPolicy limits covered recurrent GBM to supratentorial tumors

Source citationNCI definition included in policy definitions