Tumor-Treating Fields (TTF) Therapy
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Coverage policy for tumor-treating fields therapy (Optune and related devices) describing indications, medical necessity criteria, investigational exclusions, and coding for Blue Cross Blue Shield of North Carolina providers and members.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Newly diagnosed supratentorial glioblastoma (covered)
Covered when ALL of the following are met
Initial authorization should be approved for no longer than 3 months. Continuation of therapy requires documentation of lack of tumor progression while using TTF, with a brain MRI every 3 months. Progression is defined per MacDonald criteria as described in Policy Guidelines.
inv-02: Covered when ALL of the following are met (historical summary)
Policy history notes a prior change to a covered stance for newly diagnosed supratentorial glioblastoma when ALL conditions are met
This criteria set reflects the 06/29/18 policy update summarized here; supporting details and subsequent clarifications are in the policy history.
TTF therapy is considered investigational (not covered) when used as an alternative or adjunct to standard medical therapy for progressive or recurrent glioblastoma multiforme. The policy also classifies TTF as investigational for treatment of other tumor types, including but not limited to pancreatic adenocarcinoma, lung cancer, and brain metastases.
Earlier versions of this policy explicitly treated tumor‑treating fields therapy as investigational for glioblastoma. The policy history documents the service as investigational at initial adoption (10/1/2013) and through multiple reviews and clarifications (2013–2017) before subsequent coverage updates.
The evidence is insufficient to determine that TTF improves net health outcomes for several indications. For recurrent glioblastoma, randomized and comparative data have not demonstrated superiority in overall survival and existing trials are inadequate to draw firm conclusions. For malignant pleural mesothelioma and metastatic non‑small cell lung cancer, available single‑arm studies and an open‑label trial (LUNAR) are limited by study design and lack of appropriate comparators; therefore the evidence does not establish meaningful improvement in outcomes for these indications.
Prior investigational policy notes and the implementation timeline are summarized in the policy history. The service was introduced as investigational on 10/1/2013 and underwent repeated advisory and medical director reviews (2013–2017). Billing/coding updates (addition of HCPCS codes A4555 and E0766) and clarifications of noncovered indications were made during this period; the service remained investigational through the 2017 updates documented in the history.
Coding and Billing
| A4555 | HCPCS code added previously (device-related) |
| E0766 | HCPCS code added previously (device-related) |
| E1399 | Previously referenced miscellaneous supply code (removed from guidance) |
| A9900 | Previously referenced miscellaneous supply code (removed from guidance) |
| 1025T | HCPCS code added to Billing/Coding section effective 1/1/2026 |
Provider Actions and Requirements
Prior authorization required; initial auth ≤ 3 months
Initial prior authorization is required for tumor‑treating fields (TTF) therapy; initial approvals should be granted for no longer than 3 months. Continuation/renewal of authorization requires documentation of lack of tumor progression while using TTF, with surveillance brain MRI every 3 months.
- Initial authorization period ≤ 3 months
- Continuation requires brain MRI every 3 months showing no progression
Billing/coding updates — 1025T added (effective 1/1/2026)
Billing/Coding section includes HCPCS A4555 and E0766 and has added HCPCS 1025T; HCPCS code 1025T was added to the Billing/Coding section effective 1/1/2026. Inclusion of a code in the policy does not guarantee reimbursement; check administrative reimbursement guidance.
TTF must be adjunct to standard maintenance temozolomide
For newly diagnosed supratentorial glioblastoma, TTF is required to be used as an adjunct to standard maintenance temozolomide after completion of initial therapy (surgery, radiation, and concomitant chemotherapy).
- TTF must be adjunctive to maintenance temozolomide
- Must follow completion of initial surgery, radiation, and concomitant chemotherapy
No step therapy requirements described
No step therapy requirements are specified in the policy for TTF; the document does not describe any prerequisite or prior‑line therapy sequencing beyond the coverage criteria.
Submit medical records showing completion of initial therapy and required clinical elements
BCBSNC may request medical records to determine medical necessity; documentation for initial authorization must demonstrate completion of initial surgery, radiation, and concomitant chemotherapy, patient age, Karnofsky Performance Status, MRI evidence of lack of progression, and patient willingness/capability to wear the device ≥18 hours/day.
- Documentation of completion of initial surgery, radiation, and concomitant chemotherapy
- Age ≥18 and Karnofsky Performance Status ≥70%
- MRI documentation of no progression
- Evidence patient can/will wear device ≥18 hours/day
Policy documents required supporting clinical documentation elements
Policy history and updates describe required documentation elements used to determine coverage (e.g., completion of initial treatment, KPS score, documentation of lack of progression); BCBSNC may request letters of support but these are not sufficient unless all specific medical‑necessity information is included in records.
- Policy updates list required elements (completion of initial treatment, KPS, lack of progression)
- Letters of support/explanation are not sufficient unless all required information is provided
Risk of denial when used for investigational indications (progressive/recurrent GBM or other tumors)
TTF is considered investigational (not covered) when used as an alternative to or as an adjunct to standard medical therapy for progressive or recurrent glioblastoma multiforme, or when used for other tumor types (e.g., pancreatic adenocarcinoma, lung cancer, brain metastases); use in these situations may trigger claim denial.
- Investigational when used as alternative or adjunct to standard therapy for progressive/recurrent GBM
- Investigational for other tumor types including pancreatic adenocarcinoma, lung cancer, brain metastases
Investigational status history — investigational until 2018 policy change
Policy history notes the service was considered investigational for glioblastoma in earlier versions until the 06/29/2018 update that revised the statement to cover newly diagnosed supratentorial GBM meeting specified criteria; lack of meeting current criteria or historical investigational status may affect coverage determinations.
- Service listed as investigational in initial 2013 policy and subsequent updates through 2017
- 6/29/2018 update revised policy to cover newly diagnosed supratentorial GBM when criteria are met
Background
Tumor‑treating fields (TTF) deliver alternating electric fields to tumor regions via a portable device system (Optune/NovoTTF family) that uses disposable transducer arrays placed on the scalp for brain tumors or on the thoracic region for pleural disease. The device is worn continuously by the patient and supplies alternating electric fields intended to disrupt mitosis in dividing tumor cells; these systems and related regulatory summaries (PMA/SSED) are referenced in the policy scientific background.
Definitions and Device Information
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