Laser Interstitial Thermal Therapy for Neurological Conditions

POLICY NUMBER

A.7.01.170

DESCRIPTION

Laser interstitial thermal therapy (LITT) involves the introduction of a laser fiber probe to deliver thermal energy for the targeted ablation of diseased tissue. The goal of therapy is selective thermal injury through the maintenance of a sharp thermal border, as monitored via the parallel use of real-time magnetic resonance (MR) thermography and controlled with the use of actively cooled applicators. In neurological applications, LITT involves the creation of a transcranial burr hole for the placement of the laser probe at the target brain tissue. Probe position, ablation time, and intensity are controlled under MRI guidance. LITT has been proposed as a less invasive treatment option for patients with neurological conditions compared to surgery. Two LITT systems, Visualase and NeuroBlate®, have received marketing clearance from the U.S. Food and Drug Administration (FDA).

Laser Interstitial Thermal Therapy

Laser interstitial thermal therapy (LITT) involves the introduction of a laser fiber probe to deliver thermal energy for the targeted ablation of diseased tissue. Thermal destruction of tissue is mediated via DNA damage, necrosis, protein denaturation, membrane dissolution, vessel sclerosis, and coagulative necrosis. The goal of therapy is selective thermal injury through the maintenance of a sharp thermal border, as monitored via the parallel use of real-time magnetic resonance (MR) thermography and controlled with the use of actively cooled applicators. In neurological applications, LITT involves the creation of a transcranial burr hole for the placement of the laser probe at the target brain tissue. Probe position, ablation time, and intensity are controlled under magnetic resonance imaging (MRI) guidance.

The majority of neurological LITT indications described in the literature involve the ablation of primary and metastatic brain tumors, epileptogenic foci, and radiation necrosis in surgically inaccessible or eloquent brain areas. LITT may offer a minimally invasive treatment option for patients with a high risk of morbidity with traditional surgical approaches. The most common complications following LITT are transient and permanent weakness, cerebral edema, hemorrhage, seizures, and hyponatremia. Delayed neurological deficits due to brain edema are temporary and typically resolve after corticosteroid therapy. Contraindications to MRI are also applicable to the administration of LITT.

In August 2007, the Visualase MRI-Guided Laser Ablation System (Medtronic; formerly Biotex, Inc.) received initial marketing clearance by the FDA through the 510(k) pathway (K071328). In January 2022 (K211269), the system (software version 3.4) was classified as a neurosurgical tool with narrowed indications for use, including "to ablate, necrotize or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800 nm through 1064 nm lasers." The device is contraindicated for patients with medical conditions or implanted medical devices contraindicated for MRI and for patients whose physician determines that LITT or invasive surgical procedures in the brain are not acceptable. Data from compatible MRI sequences can be processed to relate imaging changes to relative changes in tissue temperature during therapy. The Visualase cooling applicator utilizes saline.

In April 2013, the NeuroBlate® System (Monteris Medical) received initial clearance for marketing by the FDA through the 510(k) pathway (K120561). As of August 2020, the system is indicated for use “to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (eg, brain tumor and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers” (K201056). The device is intended for planning and monitoring of thermal therapy under MRI guidance, providing real-time thermographic analysis of selected MRI images. The NeuroBlate system utilizes a laser probe with a sapphire capsule to promote prolonged, pulsed laser firing and a controlled cooling applicator employing pressurized CO₂.

POLICY

Laser interstitial thermal therapy (LITT) is considered investigational for all neurological indications, including but not limited to individuals with primary or metastatic brain tumors, radiation necrosis, and drug-resistant epilepsy.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

05/01/2022: New policy added. Approved by the Medical Policy Advisory Committee.

09/30/2022: Code Reference section updated to add new ICD-10 procedure codes 00500Z3, 00503Z3, and 00504Z3, effective 10/01/2022.

01/27/2023: Policy description updated regarding devices. Policy statement updated to change "patients" to "individuals."

01/17/2024: Policy description updated regarding devices. Policy statement unchanged. Code Reference section updated to remove deleted ICD-10 procedure code D0Y0KZZ.

02/24/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.170

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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