Tumor Treatment Fields - Medical Policy
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This policy governs coverage and prior authorization for FDA-approved tumor treatment field devices used for newly diagnosed or recurrent supratentorial glioblastoma multiforme across Commercial, Medicare Advantage, and Medicaid lines of business.
CPT 77299 was removed from the policy coding guidance.
CPT 1025T was added to the policy coding guidance and is identified as experimental/investigational.
The policy history records minor criteria changes in October 2025.
Medical Necessity and Coverage Criteria
Initial therapy - newly diagnosed supratentorial GBM
Covered as medically necessary and initially approved for 3 months when ALL criteria are met.
Newly diagnosed supratentorial GBM
Eligibility and treatment criteria
- Adult age: The individual is at least 18 years of age.≥18 years
- Completed initial treatment: The individual has completed initial treatment with surgery, radiation therapy, and concomitant chemotherapy.
- Performance status: The individual has a KPS score of at least 60% or an ECOG Performance Status of no more than 2.KPS ≥60% or ECOG ≤2
- No progression: There is documentation of lack of tumor progression following radiation and chemotherapy.
- Device adherence capability: The individual is willing and capable of wearing the device for at least 18 hours per day.≥18 hours/day
Initial therapy - recurrent supratentorial GBM
Covered as medically necessary and approved for 3 months when ALL criteria are met.
Recurrent supratentorial GBM
- Recurrence confirmed: The recurrence in the supratentorial region of the brain is histologically or radiologically confirmed after chemotherapy.
- Performance status: The individual has a KPS score of at least 60% or an ECOG Performance Status of no more than 2.KPS ≥60% or ECOG ≤2
- Monotherapy and exhausted standard options: The device is intended as monotherapy and as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
- Initial device compliance: There is documentation of compliance with device use during initial treatment for at least 18 hours per day.≥18 hours/day
Continuation therapy beyond 3 months
Continuation beyond the initial 3 months is based on ALL criteria.
Continuation of TTF for histologically confirmed supratentorial GBM
- Stable MRI: An MRI has been performed no more than 2 months before the request and documents no evidence of disease progression.MRI ≤2 months before request
ONE of: Appropriate treatment context
- Newly diagnosed continuation: The individual with newly diagnosed glioblastoma continues to receive temozolomide as the only cancer drug.
- Recurrent continuation: The device is used as the only treatment for an individual with recurrent GBM.
- Performance status: The individual has a KPS score of at least 60% or an ECOG Performance Status of no more than 2.KPS ≥60% or ECOG ≤2
- Ongoing device adherence: There is documentation that the individual has been using the device at least 18 hours daily.≥18 hours/day
Unproven or investigational TTF device uses
Considered experimental and investigational.
Experimental or investigational uses
- Other tumor types: Treatment of tumors other than glioblastoma multiforme.
- Concurrent recurrent-GBM therapy: Use of electric TTF therapy with concurrent medical therapy, such as bevacizumab or chemotherapy, for recurrent GBM.
Experimental treatment-planning software
Considered experimental and investigational.
TTF treatment for tumors other than glioblastoma multiforme (GBM) is excluded from medically necessary coverage and is considered experimental and investigational.
Concurrent electric TTF therapy with bevacizumab or chemotherapy for recurrent GBM is considered experimental and investigational. Covered recurrent-GBM use requires TTF therapy as monotherapy after surgical and radiation options have been exhausted.
Computer software used for therapeutic radiology clinical treatment planning in conjunction with TTF therapy is considered experimental and investigational because of insufficient evidence of efficacy.
Coding Guidance and Clinical Thresholds
| 1025T | Alternating electric fields dosimetry and delivery-simulation modeling, creation and selection of patient-specific array layouts, and placement verification. |
| 1025T | Alternating electric fields dosimetry and delivery-simulation modeling, creation and selection of patient-specific array layouts, and placement verification. |
Authorization, Documentation, and Denial Risks
Prior Authorization Required for TTF Therapy
Prior authorization is required for TTF therapy using an FDA-approved device billed under HCPCS E0766. Requests must document that the applicable medical-necessity criteria are met for newly diagnosed or recurrent supratentorial GBM.
- Newly diagnosed supratentorial GBM: age ≥18; completion of surgery, radiation, and concomitant chemotherapy; KPS ≥60% or ECOG ≤2; no documented tumor progression after radiation and chemotherapy; and willingness and ability to wear the device at least 18 hours daily.
- Recurrent supratentorial GBM: histologically or radiologically confirmed recurrence after chemotherapy; KPS ≥60% or ECOG ≤2; use as monotherapy and an alternative after surgical and radiation options are exhausted; and documented initial-treatment use of at least 18 hours daily.
- Initial approval is generally for 3 months; continuation requires the applicable continuation criteria.
E0766 Authorization Requirement
Authorization is required for the electrical stimulation device used for cancer treatment, including all accessories, when billed under HCPCS E0766. Replacement electrodes/transducers billed under A4555 do not require authorization according to the coding guidance.
Unsupported block type: documentationιο
Newly Diagnosed GBM Documentation
For newly diagnosed glioblastoma, include documentation supporting the diagnosis and required prior treatment, functional status, and counseling about device use.
- Diagnosis of newly diagnosed glioblastoma.
- Prior radiation-treatment documentation.
- Karnofsky Performance Status (KPS) or Eastern Cooperative Oncology Group (ECOG) Performance Status results.
- Documentation that the member was counseled to wear the device at least 18 hours daily.
Continuation Documentation
Requests to continue TTF therapy beyond the initial 3 months must include recent imaging and evidence that the applicable treatment, performance-status, and device-use requirements remain satisfied.
- Date and results of an MRI performed no more than 2 months before the request, documenting no disease progression.
- For newly diagnosed GBM, documentation that temozolomide is the only cancer drug; for recurrent GBM, documentation that the device is the only treatment.
- KPS ≥60% or ECOG ≤2.
- Documentation that the member has used the device at least 18 hours per day.
Recurrent GBM Documentation
For treatment of recurrent glioblastoma, submit documentation confirming the recurrence, functional status, and counseling regarding required device use.
- Diagnosis of recurrent glioblastoma.
- KPS or ECOG Performance Status results.
- Documentation that the member was counseled to wear the device at least 18 hours daily.
Unsupported block type: documentation
Failure to Meet Medical-Necessity Criteria
TTF therapy may be denied as not medically necessary when the applicable approval criteria are not met. The request must support the patient’s age, required prior treatment, functional status, disease status, and required device-use conditions.
- Newly diagnosed GBM: the patient must be ≥18, have completed surgery, radiation, and concomitant chemotherapy, have KPS ≥60% or ECOG ≤2, have no documented progression after radiation and chemotherapy, and be willing and capable of wearing the device at least 18 hours daily.
- Recurrent GBM: the recurrence must be histologically or radiologically confirmed in the supratentorial region after chemotherapy; KPS must be ≥60% or ECOG ≤2; the device must be used as monotherapy after surgical and radiation options are exhausted; and initial device use must have been at least 18 hours daily.
- Continuation beyond 3 months requires recent MRI showing no progression, the applicable single-drug or device-only treatment status, KPS ≥60% or ECOG ≤2, and documented device use of at least 18 hours daily.
Unapproved Indication or Concurrent Recurrent-Disease Therapy
TTF devices are experimental and investigational for indications outside the policy’s approved criteria. Requests may be denied when the device is used for non-GBM tumors or with concurrent medical therapy for recurrent GBM.
- Treatment of tumors other than GBM is experimental and investigational.
- Electric TTF therapy used with concurrent medical therapy, such as bevacizumab or chemotherapy, for recurrent GBM is experimental and investigational.
Experimental Treatment-Planning Software
Computer software used for therapeutic-radiology clinical treatment planning in conjunction with TTF therapy is considered experimental and investigational because of insufficient evidence of efficacy.
- Do not assume that treatment-planning software used with TTF therapy is a covered service.
Experimental/Investigational CPT 1025T
Requests billed with CPT 1025T may be denied because the service is classified as experimental and investigational.
Insufficient Clinical Documentation
Requests may not be properly reviewed when the required clinical evidence and supporting information are missing. Submit complete documentation showing that the patient meets the applicable criteria for the requested service.
- The treating physician or primary care provider must provide the clinical evidence.
- Missing diagnosis, treatment history, performance status, imaging, treatment-status, counseling, or device-use documentation may prevent review of the prior-authorization request.
Therapy Overview
Tumor treatment fields (TTF) are noninvasive alternating electrical fields delivered through transducer arrays applied to a shaved scalp. A portable device supplies the fields through the arrays, which are worn over the treatment area. The therapy is addressed for newly diagnosed or recurrent supratentorial glioblastoma multiforme, generally as an adjunct to maintenance temozolomide after standard postoperative treatment for newly diagnosed disease or as monotherapy after standard surgical and radiation options have been exhausted for recurrent disease.
Clinical Terms and Measures
Treatment Setting
First-line treatment context
In the first-line setting, TTF is covered as an adjunct to standard maintenance temozolomide after completion of initial therapy when ALL criteria are met.
First-line treatment for newly diagnosed supratentorial GBM
- Adult age: The individual is at least 18 years of age.≥18 years
- Performance status: The individual has a KPS score of at least 60% or an ECOG Performance Status of no more than 2.KPS ≥60% or ECOG ≤2
- No progression: There is documentation of lack of tumor progression following radiation and chemotherapy.
- Device adherence capability: The individual is willing and capable of wearing the device for at least 18 hours per day.≥18 hours/day
Salvage treatment context
In the salvage setting, TTF is covered for recurrent supratentorial GBM as monotherapy after standard surgical and radiation options have been exhausted.
Salvage treatment for recurrent supratentorial GBM
- Recurrence confirmed: Recurrence in the supratentorial region of the brain is histologically or radiologically confirmed after chemotherapy.
- Performance status: The individual has a KPS score of at least 60% or an ECOG Performance Status of no more than 2.KPS ≥60% or ECOG ≤2
- Initial device compliance: There is documentation of compliance with device use during initial treatment for at least 18 hours per day.≥18 hours/day
- No concurrent medical therapy: TTF is not used concurrently with bevacizumab or chemotherapy for recurrent GBM; such concurrent use is experimental and investigational.
Covered Treatment Regimens
| Regimen | Clinical setting | Coverage |
|---|---|---|
| TTF therapy with an FDA-approved device as an adjunct to maintenance temozolomide | Newly diagnosed supratentorial glioblastoma multiforme after surgery, radiation therapy, and concomitant chemotherapy | Covered as medically necessary; initially approved for 3 months when applicable criteria are met |
| Regimen | Clinical setting | Coverage |
|---|---|---|
| TTF therapy as monotherapy | Recurrent supratentorial GBM after chemotherapy, with surgical and radiation options exhausted | Covered as medically necessary; approved for 3 months when applicable criteria are met |
| Regimen | Clinical setting | Coverage |
|---|---|---|
| TTF therapy combined with concurrent medical therapy | Recurrent GBM treated concurrently with bevacizumab or chemotherapy | Experimental and investigational; not covered |
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