CurrentUnitedHealthcarePolicy CS146NJ.J

Electric Tumor Treatment Field Therapy (for New Jersey Only) – Community Plan Medical Policy

UnitedHealthcare New Jersey–only medical policy describing coverage criteria, continuation criteria, definitions, applicable procedure codes, and evidence summary for electric tumor treatment field (TTF) therapy (e.g., Optune) primarily for newly diagnosed and recurrent supratentorial glioblastoma (GBM).

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for New Jersey Only)

Policy CodePolicy CS146NJ.J

Change TypeCoverage language, documentation, and coding updates

Effective DateJan 1, 2026

Next Review Date

Key ActionEnsure initial authorization documents demonstrate all initial coverage criteria are met and verify NJ Medicaid coverage for HCPCS E0767 before billing.

SourceLink

POLICY UPDATE CHANGES

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

Added language to Medical Records Documentation Used for Reviews specifying documentation expectations and that coverage is governed by federal/state/contractual requirements.

Removed CPT code 77299 from Applicable Codes.

Added notation that HCPCS code E0767 is not on the State of New Jersey Medicaid Fee Schedule and therefore may not be covered by the State of New Jersey Medicaid Program.

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the most current information.

2Covered Indications (ndGBM, rGBM)

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Coverage Summary

This UnitedHealthcare New Jersey medical policy (Policy Number CS146NJ.J, effective January 1, 2026) addresses coverage for electric tumor treatment field (TTF) therapy (e.g., Optune) with a mixed coverage stance: covered for specific GBM indications under defined criteria and not covered for other or nonconforming uses. The policy scope is limited to New Jersey and focuses on newly diagnosed supratentorial glioblastoma (ndGBM) and recurrent supratentorial glioblastoma (rGBM). Initial authorization for either ndGBM or rGBM is for 3 months, with continuation contingent on meeting specified follow-up requirements and thresholds (performance status, MRI recency, continued temozolomide as applicable, and documented device use).

Medical Necessity Criteria

Covered when ALL of the following are met:

ALL of the following

Histologically confirmed supratentorial glioblastoma (GBM)
Debulking surgery has been completed
Newly diagnosed supratentorial GBM (ndGBM) only
Treatment with radiation therapy has been completed
ndGBM only
Individual is receiving Temozolomide (TMZ) as the only cancer drug
ndGBM only
Individual has a Karnofsky Performance Status (KPS) score of ≥ 60 or Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Individual has been counseled that the electric TTF device must be worn at least 18 hours daily
Initial approval duration
- Initial approval duration: 3 months of electric TTF therapy

Continuation (Subsequent) Approval Criteria

Magnetic resonance imaging (MRI) scan has been performed ≤ 2 months prior to request and documents no evidence of disease progression
MRI must be recent to confirm stability
Individual with ndGBM continues to receive TMZ as the only cancer drug or, for rGBM, the device is used as the only treatment
Continued TMZ for ndGBM; device-only for rGBM
KPS score of ≥ 60 or ECOG Performance Status ≤ 2
Documentation that the individual has been using the electric TTF device at least 18 hours daily
Provider should document device usage (e.g., device logs or provider notes)

Not Medically Necessary / Not Covered

Treatment of tumors other than glioblastoma (GBM)
Use of electric TTF therapy with concurrent systemic medical therapy (e.g., bevacizumab or chemotherapy) for treatment of recurrent GBM (rGBM)
Clinical criteria for coverage are not met (including but not limited to KPS < 60 or ECOG > 2, inadequate device usage, lack of required imaging, or concurrent disallowed therapies)

Coverage Rationale & Evidence Summary

Tumor-treating fields (TTF; also marketed as Optune) deliver low-intensity, intermediate-frequency electric fields (100–300 kHz) via transducer arrays placed on the scalp connected to a portable generator; treatment is noninvasive and typically recommended for at least 18 hours/day. The Optune kit includes the generator, transducer arrays, power supply, and supplies; arrays are changed regularly and the scalp is maintained for optimal contact. While FDA approvals exist for GBM indications (initial PMA for recurrent GBM and a supplemental PMA for use with temozolomide in newly diagnosed supratentorial GBM), TTF is investigational or under study for other solid tumors (e.g., NSCLC, mesothelioma, pancreatic, ovarian, brain metastases).

Coverage rationale summary: the policy supports use of an FDA‑approved TTF device for newly diagnosed supratentorial GBM after surgery, radiation, and during adjuvant temozolomide when performance status and counseling/wear-time criteria are met, and for recurrent supratentorial GBM as device-only therapy when criteria are met; continuation beyond the initial 3 months requires recent MRI without progression and documentation of ongoing device use and performance status. The policy also states that use is unproven and not medically necessary when criteria are not met or for other tumor indications.

Guideline positions are mixed: ASCO/SNO (2022) allows adding alternating electric field therapy to adjuvant temozolomide for newly diagnosed supratentorial GBM (weak recommendation), NCCN includes alternating electric fields as an option for ndGBM and recognizes FDA approvals for ndGBM and rGBM (panel divided for rGBM), EANO (2021) is cautious and recommends against using treatments beyond confirmed progression including TTF in some recurrence settings, and NICE (2018, updated 2021) recommends not offering TTF for newly diagnosed grade IV glioma or for recurrent high-grade glioma due to insufficient evidence.

Evidence	Findings / Notes
EF-14 randomized trial (Stupp et al., 2015/2017)	Addition of TTFields to maintenance temozolomide improved PFS and OS (median PFS ~6.7–7.1 vs ~4.0 months; median OS ~20.9 vs 16.0 months; HR ~0.63), with mainly mild-moderate under-array skin toxicity and no increase in systemic toxicity
Compliance association	Higher device compliance associated with improved OS/PFS; threshold effects reported (≥50% and ≥75%); >90% compliance associated with median survival ~24.9 months and higher 5-year survival
Safety	Most common AEs are dermatologic skin reactions under transducer arrays (predominantly grade 1–2); systemic toxicity not increased when combined with TMZ; post‑marketing data show mainly mild/moderate skin AEs
STELLAR (mesothelioma, single-arm phase II)	Median OS 18.2 months (95% CI 12.1–25.8) in n=80; skin reactions grade 1–2 in 66% and grade 3 in 5%; encouraging safety but lack of comparator limits conclusions
LUNAR (metastatic NSCLC, randomized phase III)	TTFields added to standard systemic therapy after platinum progression showed improved overall survival versus standard therapy alone; most TTFields‑related AEs were grade 1–2 skin disorders; no deaths attributed to TTFields
STELLAR safety notes	TTFields-related skin AEs common (majority grade 1–2); systemic grade ≥3 AEs driven by chemotherapy components; no treatment‑related deaths reported
Systematic reviews / meta-analyses (ndGBM & rGBM)	Meta-analyses show improved median OS and PFS for ndGBM with TTFields added to SOC; for rGBM evidence suggests possible benefit though data and trial quality vary; dermatologic AEs predominate
Post-marketing safety surveillance	Analysis of >11,000 TTFields-treated individuals found array-associated skin reactions most common (≈30–38%), mostly mild/moderate; no new safety concerns identified

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required — Initial Therapy

Prior authorization is required for initial electric TTF therapy for newly diagnosed supratentorial GBM. Requests must show the member meets all listed conditions.

Debulking surgery and radiation therapy have been completed for newly diagnosed GBM (ndGBM).
Individual is receiving Temozolomide (TMZ) as the only cancer drug for ndGBM.
Karnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2.
Individual has been counseled that the electric TTF device must be worn at least 18 hours daily.
When all criteria are met for ndGBM, an initial 3 months of electric TTF therapy will be approved.

Prior Authorization

Prior Authorization Required — Continuation Therapy

Prior authorization is required for continuation of electric TTF therapy beyond the initial 3 months. Requests must document ongoing eligibility and device use.

Applicable Codes

Referenced HCPCS / Procedure Codes (reference only)HCPCS

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

Removed/Deleted CPT codesCPTNot Covered

77299

Unlisted procedure, therapeutic radiology (removed from Applicable Codes list)

HCPCS noted as not on State Medicaid Fee ScheduleHCPCS

E0767

Tumor treating fields device (Optune) — notation: E0767 is not on the State of New Jersey Medicaid Fee Schedule and therefore may not be covered by the State of New Jersey Medicaid Program

Definitions

Supratentorial: Upper portion of the brain comprising the cerebrum, ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve.

Temozolomide (TMZ): Oral alkylating chemotherapy drug used as first-line treatment for glioblastoma.

ECOG Performance Status: Scale (0–5) measuring disease impact on functioning; policy eligibility requires ≤ 2.

Karnofsky Performance Status (KPS): Scale (0–100) measuring ability to perform daily activities; policy eligibility requires ≥ 60.

TTFields (Tumor treating fields): Alternating electric fields delivered via the Optune device to disrupt tumor cell division; treatment parameters are preset and arrays are placed on the scalp with recommended use of at least 18 hours/day.

ndGBM: Newly diagnosed supratentorial glioblastoma.

rGBM: Recurrent supratentorial glioblastoma.

Revision History

01/01/2026removed - coverage_rationale (material)Latest

01/01/2026added - medical_records_documentation (material)Latest

Added language to Medical Records Documentation Used for Reviews specifying that benefit coverage is determined by federal, state, or contractual requirements; medical records may be required but do not guarantee coverage; the patient's medical record must fully support medical necessity; documentation examples and that records must be legible and made available upon request.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for New Jersey Only)

Policy CodePolicy CS146NJ.J

Change TypeCoverage language, documentation, and coding updates

Effective DateJan 1, 2026

Next Review Date

Key ActionEnsure initial authorization documents demonstrate all initial coverage criteria are met and verify NJ Medicaid coverage for HCPCS E0767 before billing.

SourceLink

On This Page

Documentation Required

Documentation Requirements — Medical Records

Medical record documentation must fully support the medical necessity for the requested TTF therapy. Records must be legible, maintained in the patient's medical record, and made available upon request. Benefit coverage is determined by federal, state, or contractual requirements and applicable laws which may require coverage for a specific service; such requirements govern coverage determination.

Relevant medical history and physical examination notes supporting diagnosis of supratentorial GBM.
Histologic confirmation of glioblastoma when applicable.
Operative reports demonstrating completion of debulking surgery (if applicable).
Radiation therapy records documenting completion of radiation (for ndGBM initial approval).
Chemotherapy records showing Temozolomide (TMZ) as the sole cancer drug when required.
Recent MRI reports (as required for continuation requests) and other pertinent diagnostic test results.
Performance status documentation (KPS and/or ECOG) meeting policy thresholds.
Documentation of counseling regarding device wear time and adherence, and device usage logs showing ≥ 18 hours/day when required.

Billing Rule

Billing Rule — NJ Medicaid Fee Schedule

Billing providers: verify New Jersey Medicaid coverage before billing for HCPCS E0767. Items marked exempt from the NJ Medicaid fee schedule may not be covered; confirm eligibility and coverage rules prior to claim submission.

HCPCS code E0767 — Intrabuccal, systemic delivery of amplitude-modulated, radiofrequency electromagnetic field device, for cancer treatment, includes all accessories.
Note: Codes labeled with an asterisk in this policy are not on the State of New Jersey Medicaid Fee Schedule and therefore may not be covered by the State of New Jersey Medicaid Program. Verify NJ Medicaid coverage before billing.