Tumor-Treatment Fields (TTF) Therapy
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This policy governs medical necessity coverage for tumor-treatment fields (TTF) therapy (Optune and related systems) for specific oncology indications and describes when TTF is considered medically necessary, investigational, billing codes, and supporting evidence; it applies to Blue Cross Blue Shield of North Carolina members and their providers.
No material clinical or coverage changes in this revision.
Coverage Criteria for Tumor-Treatment Fields (TTF) Therapy
Newly Diagnosed Supratentorial Glioblastoma (Covered with Criteria)
Covered when ALL of the following are met:
Initial authorization should be approved for no longer than 3 months; continuation requires documentation of lack of tumor progression while using TTF with brain MRI every 3 months.
When Covered — Newly diagnosed supratentorial glioblastoma (adjunct to maintenance temozolomide)
Covered when ALL of the following are met:
Applies to newly diagnosed supratentorial glioblastoma as adjunct to maintenance temozolomide (policy update 06/29/18).
When Covered — Continuation therapy / sequencing
Continuation therapy criteria added 2/12/19:
See Policy Guidelines and prior authorization requirements for monitoring (e.g., MRI every 3 months).
Recurrent GBM and Other Indications (Not Covered / Investigational)
TTF is considered investigational (not covered) in the following situations:
Randomized and high-quality comparative evidence is insufficient to determine net health benefit for these indications.
The policy considers tumor‑treating fields (TTF) therapy investigational when used as an alternative or adjunct to standard medical therapy for progressive or recurrent glioblastoma multiforme (GBM). It is also considered investigational for the treatment of other tumor types, including but not limited to pancreatic adenocarcinoma, lung cancer, and brain metastases. Requests for coverage in these situations are subject to denial because current evidence does not establish a net health benefit for these indications.
Historically, earlier iterations of this policy listed tumor‑treating fields as investigational for glioblastoma. The policy record documents repeated specialty and medical director reviews beginning with the original policy on 10/1/2013 that maintained an investigational stance through multiple reviews and guideline updates. Over time, specific clarifications were added to the policy's coverage statements and billing/coding sections (for example, addition of HCPCS A4555 and E0766 on 12/31/2013), and later updates refined indications and implementation details while preserving the documented review history.
For individuals with recurrent or progressive GBM who receive TTF therapy as an adjunct or alternative to standard medical therapy, available evidence—comprising a randomized trial, nonrandomized comparative studies, and systematic reviews—does not demonstrate superiority in overall survival. The randomized trial did not show improved OS versus physicians'‑choice chemotherapy, and the trial design did not support noninferiority conclusions. Systematic reviews and registry comparisons yield pooled median outcomes but lack the high‑quality prospective evidence needed to establish a net health benefit. Therefore, for recurrent GBM the evidence is insufficient and TTF is considered investigational (not covered) for this indication.
Earlier policy versions explicitly categorized TTFields as investigational for glioblastoma and enumerated specific investigational or non‑covered uses. These included use as an alternative to standard chemotherapy for progressive or recurrent GBM and use as an adjunct to standard maintenance therapy outside of the defined newly diagnosed supratentorial GBM criteria. The policy implementation history documents multiple reviews and clarifications (10/1/2013 initial policy and subsequent updates) that maintained an investigational designation for these uses until coverage criteria for select newly diagnosed patients were established in later updates.
Provider Actions, Authorization, and Documentation Requirements
Authorization timeframe and monitoring
Initial authorizations for TTF therapy must be approved for no longer than 3 months. For continued coverage, submit documentation showing lack of tumor progression while using TTF with brain MRI surveillance every 3 months.
- Initial authorization ≤ 3 months
- Continuation requires brain MRI every 3 months showing no progression
Adjunct to temozolomide required
TTF is covered for newly diagnosed supratentorial glioblastoma only when used as an adjunct to standard maintenance therapy with temozolomide after completion of initial therapy (surgery, radiation, and concomitant chemotherapy).
- Must be given as adjunct to maintenance temozolomide
- Applies to newly diagnosed supratentorial GBM after completion of initial therapy
Policy requires TTF as adjunct to maintenance temozolomide
Ensure TTF is ordered only as an adjunct to standard maintenance temozolomide for newly diagnosed supratentorial glioblastoma; do not sequence TTF as an alternative to initial standard therapy.
- TTF establishes sequencing expectations relative to initial treatments (surgery, radiation, concomitant chemotherapy)
- Policy statement specifies adjunct use with temozolomide
Required clinical documentation
Include records demonstrating completion of initial surgery, radiation therapy, and concomitant chemotherapy; patient age (≥18); Karnofsky Performance Status (≥70%); MRI evidence of no progression after radiation/chemotherapy; and documentation the patient is willing and capable of wearing the device ≥18 hours/day.
- Completion of initial surgery, radiation, and concomitant chemotherapy
- Patient age ≥18 years
- Karnofsky Performance Status ≥70%
- MRI documentation of lack of progression after radiation and chemotherapy
- Evidence patient can/will wear device ≥18 hours/day
Documentation operational details
Operationally, include supporting medical records (not just letters) that document completion of initial treatment, age, KPS, imaging showing no progression, and patient’s willingness/capability to wear TTF ≥18 hours/day; BCBSNC may request medical records to determine medical necessity.
- Medical records may be requested; letters alone are insufficient unless they contain all needed medical-necessity information
- Document patient willingness/capability to wear device ≥18 hours/day
Investigational indications trigger denial
Deny requests for TTF when requested as an alternative or adjunct to standard medical therapy for progressive or recurrent GBM, or when requested for other tumor types (e.g., pancreatic adenocarcinoma, lung cancer, brain metastases), because these uses are considered investigational.
- Recurrent/progressive GBM as alternative/adjunct to standard therapy is investigational and subject to denial
- Use in other tumor types (pancreatic adenocarcinoma, lung cancer, brain metastases) is investigational
Coverage gating summary — meet all specified criteria
Coverage is granted only when all listed criteria are met: completion of initial surgery, radiation, and concomitant chemotherapy; age ≥18 years; Karnofsky Performance Status ≥70%; documentation of lack of tumor progression after radiation/chemotherapy; and willingness/capability to wear the device ≥18 hours/day. Failure to meet any criterion may result in noncoverage.
- All criteria must be met for coverage
- Failure to document any requirement can trigger denial or noncoverage
Billing and Coding Information
| 1025T | HCPCS added to Billing/Coding section effective 1/1/2026 |
Definitions and Device References
Background on Tumor-Treating Fields (TTF)
Tumor‑treating fields (TTF) are delivered by external, battery‑powered, portable systems (e.g., the Optune and NovoTTF family) that generate low‑intensity, alternating electric fields applied to the scalp via disposable transducer arrays. The technology is noninvasive and designed for prolonged daily use; therapeutic intent is to disrupt mitotic processes in tumor cells and thereby slow tumor growth. Devices referenced in regulatory summaries include models such as the NovoTTF‑100A/100L/200A/200T and Optune variants, which are intended to provide continuous alternating electric fields while allowing ambulatory use.
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